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3. Provision and uptake of sexual and reproductive health services during the COVID-19 pandemic: The case of Mali

Author

Haidara, Fadima C., Keita, Adama M., Ducker, Camilla, Diarra, Kounandji, Djiteye, Mahamane, Marlow, Heather, Goodwin, Emily, Martell, Owen, Izugbara, Chimaraoke, and Sow, Samba

Subjects
Urban health, Epidemics -- Mali, Health care industry, Reproductive health, Health care industry, Business, General interest, Business, international, News, opinion and commentary, World Bank Group. World Bank
Abstract

A qualitative study assessed the effects of the COVID-19 epidemic on Malian sexual and reproductive health services. Sexual and reproductive health (SRHR) providers in 25 purposively selected public health facilities in urban Bamako, rural Kita (western Mali) and Koutiala (southeast Mali) were interviewed. Disruptions within SRH supply, staffing, the prioritization of SRHR services, and patients' ability to seek, obtain and pay for services were reported across urban and rural settings at all levels of public health care, and by all cadres of SRHR providers. Most facilities in the study areas sustained some SRHR services at the height of the COVID19 epidemic through innovative outreach and phone-based consultations. This study offers critical lessons for SRHR service provision during future waves of the pandemic or during periods of comparable emergency. (Afr J Reprod Health 2022; 26[12s]: 169-179). Keywords: Sexual reproductive health, COVID-19 disruption, essential services, Mali Une étude qualitative a évalué les effets de l'épidémie de COVID-19 sur les services maliens de santé sexuelle et reproductive. Des prestataires de santé sexuelle et reproductive (SRHR) dans 25 établissements de santé publique sélectionnés àdessein dans les zones urbaines de Bamako, Kita rurale (ouest du Mali) et Koutiala (sud-est du Mali) ont été interrogés. Les perturbations au sein de l'offre de SSR, du personnel, de la hiérarchisation des services de SDSR et de la capacité des patients àrechercher, obtenir et payer des services ont été signalées dans les milieux urbains et ruraux àtous les niveaux des soins de santé publics et par tous les cadres de prestataires de SDSR. La plupart des établissements dans les zones d'étude ont maintenu certains services de SDSR au plus fort de l'épidémie de COVID-19 grâce àdes consultations innovantes et par téléphone. Cette étude offre des leçons essentielles pour la prestation de services de SDSR lors des futures vagues de la pandémie ou pendant des périodes d'urgence comparables. (Afr JReprod Health 2022; 26[12s]: 169-179). Mots-clés: Santé sexuelle et reproductive, perturbation du COVID-19, services essentiels, Mali, Introduction Public health service provision in Mali is constrained by a high disease burden, frequent national-level insecurity, a high fertility rate, low expenditure on health, mistrust of government services, ineffective [...]

Published
2023
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4. Strengthening local capacity for abortion-related research in contexts with highly restrictive abortion laws: The case of STARS in Mali

Author

Sow, Samba, Izugbara, Chimaraoke, Diarra, Kounandji, Djiteye, Mahamane, Keita, Adama M., Haidara, Fadima C., Marlow, Heather, Leasure, Erin, Martell, Owen, and Ducker, Camilla

Subjects
Abortion -- Political aspects -- Laws, regulations and rules, Reproductive health -- Laws, regulations and rules, Government regulation, Business, General interest, Business, international, News, opinion and commentary
Abstract

Strong local abortion research capacity is missing in many African countries. We report on the Strengthening Abortion Research Capacity in sub-Saharan Africa (STARS) program, an ongoing initiative to strengthen local capacity for abortion research in Mali, West Africa. We highlight the background, context, and methodology of the initiative as well as its achievements, challenges, and emerging lessons. Within a short time, STARS has initiated some key studies on abortion in Mali and created a much-needed platform for nurturing the country's next generation of abortion researchers, institutionalizing abortion research, increasing the quantity and quality of locally generated evidence on abortion, and facilitating evidence-informed abortion policy and programmatic action. The program's learning-by-doing approach has boosted the skills of individual researchers while also enhancing institution-based abortion and sexual and reproductive health and rights (SRHR) research expertise in Mali. Although STARS' capacity to deliver its mandate over time is evident, ultimate results will depend on the sustained commitment of funders to the program in the full realization that capacity building requires long-term investment and support for it to fully bear fruits. (Afr JReprodHealth 2022; 26[12s]: 110-118). Keywords: Abortion, research capacity, Mali, STARS De solides capacités locales de recherche sur l'avortement font défaut dans de nombreux pays africains. Nous rendons compte du programme de renforcement des capacités de recherche sur l'avortement en Afrique subsaharienne (STARS), une initiative en cours visant àrenforcer les capacités locales de recherche sur l'avortement au Mali, en Afrique de l'Ouest. Nous soulignons le contexte, le contexte et la méthodologie de l'initiative ainsi que ses réalisations, ses défis et les leçons émergentes. En peu de temps, STARS a lancé des études clés sur l'avortement au Mali et créé une plate-forme indispensable pour nourrir la prochaine génération de chercheurs sur l'avortement du pays, institutionnaliser la recherche sur l'avortement, augmenter la quantité et la qualité des preuves générées localement sur l'avortement et faciliter politique d'avortement fondée sur des données probantes et action programmatique. L'approche d'apprentissage par la pratique du programme a renforcé les compétences des chercheurs individuels tout en renforçant l'expertise de recherche institutionnelle sur l'avortement et la santé et les droits sexuels et reproductifs (SDSR) au Mali. Bien que la capacité de STARS àremplir son mandat au fil du temps soit évidente, les résultats ultimes dépendront de l'engagement soutenu des bailleurs de fonds envers le programme dans la pleine conscience que le renforcement des capacités nécessite un investissement et un soutien àlong terme pour qu'il porte pleinement ses fruits. (Afr JReprodHealth 2022; 26[12s]: 110-118). Mots-clés: Avortement, capacité de recherche, Mali, STARS, Introduction Many African countries lack strong local abortion research capacity. Yet, this capacity is critical for the continent's realization of the United Nations' Sustainable Development Goals (SDGs) that are related [...]

Published
2023
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5. Quantifying the Cost of Shigella Diarrhea in the Enterics for Global Health (EFGH) Shigella Surveillance Study

Author

Morozoff, Chloe, primary, Ahmed, Naveed, additional, Chinkhumba, Jobiba, additional, Islam, Md Taufiqul, additional, Jallow, Abdoulie F, additional, Ogwel, Billy, additional, Zegarra Paredes, Loyda Fiorella, additional, Sanogo, Doh, additional, Atlas, Hannah E, additional, Badji, Henry, additional, Bar-Zeev, Naor, additional, Conteh, Bakary, additional, Güimack Fajardo, Mario, additional, Feutz, Erika, additional, Haidara, Fadima C, additional, Karim, Mehrab, additional, Mamby Keita, Adama, additional, Keita, Youssouf, additional, Khanam, Farhana, additional, Kosek, Margaret N, additional, Kotloff, Karen L, additional, Maguire, Rebecca, additional, Mbutuka, Ishmail S, additional, Ndalama, Maureen, additional, Ochieng, John Benjamin, additional, Okello, Collins, additional, Omore, Richard, additional, Perez Garcia, Karin F, additional, Qamar, Farah Naz, additional, Qudrat-E-Khuda, Syed, additional, Qureshi, Sonia, additional, Rajib, Md Nazmul Hasan, additional, Shapiama Lopez, Wagner Valentino, additional, Sultana, Shazia, additional, Witte, Desiree, additional, Yousafzai, Mohammad Tahir, additional, Awuor, Alex O, additional, Cunliffe, Nigel A, additional, Jahangir Hossain, M, additional, Paredes Olortegui, Maribel, additional, Tapia, Milagritos D, additional, Zaman, K, additional, and Means, Arianna Rubin, additional

Published
2024
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6. Diarrhea Case Surveillance in the Enterics for Global Health Shigella Surveillance Study: Epidemiologic Methods

Author

Atlas, Hannah E, primary, Conteh, Bakary, additional, Islam, Md Taufiqul, additional, Jere, Khuzwayo C, additional, Omore, Richard, additional, Sanogo, Doh, additional, Schiaffino, Francesca, additional, Yousafzai, Mohammad Tahir, additional, Ahmed, Naveed, additional, Awuor, Alex O, additional, Badji, Henry, additional, Cornick, Jennifer, additional, Feutz, Erika, additional, Galagan, Sean R, additional, Haidara, Fadima C, additional, Horne, Bri’Anna, additional, Hossen, Md Ismail, additional, Hotwani, Aneeta, additional, Houpt, Eric R, additional, Jallow, Abdoulie F, additional, Karim, Mehrab, additional, Keita, Adama Mamby, additional, Keita, Youssouf, additional, Khanam, Farhana, additional, Liu, Jie, additional, Malemia, Thandizo, additional, Manneh, Alhagie, additional, McGrath, Christine J, additional, Nasrin, Dilruba, additional, Ndalama, Maureen, additional, Ochieng, John Benjamin, additional, Ogwel, Billy, additional, Paredes Olortegui, Maribel, additional, Zegarra Paredes, Loyda Fiorella, additional, Pinedo Vasquez, Tackeshy, additional, Platts-Mills, James A, additional, Qudrat-E-Khuda, Syed, additional, Qureshi, Sonia, additional, Hasan Rajib, Md Nazmul, additional, Rogawski McQuade, Elizabeth T, additional, Sultana, Shazia, additional, Tennant, Sharon M, additional, Tickell, Kirkby D, additional, Witte, Desiree, additional, Peñataro Yori, Pablo, additional, Cunliffe, Nigel A, additional, Hossain, M Jahangir, additional, Kosek, Margaret N, additional, Kotloff, Karen L, additional, Qadri, Firdausi, additional, Qamar, Farah Naz, additional, Tapia, Milagritos D, additional, and Pavlinac, Patricia B, additional

Published
2024
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10. Meningococcal ACWYX Conjugate Vaccine in 2-to-29-Year-Olds in Mali and Gambia

Author

Haidara, Fadima C., primary, Umesi, Ama, additional, Sow, Samba O., additional, Ochoge, Magnus, additional, Diallo, Fatoumata, additional, Imam, Abdulazeez, additional, Traore, Youssouf, additional, Affleck, Lucy, additional, Doumbia, Moussa F., additional, Daffeh, Bubacarr, additional, Kodio, Mamoudou, additional, Wariri, Oghenebrume, additional, Traoré, Awa, additional, Jallow, Edrissa, additional, Kampmann, Beate, additional, Kapse, Dhananjay, additional, Kulkarni, Prasad S., additional, Mallya, Asha, additional, Goel, Sunil, additional, Sharma, Pankaj, additional, Sarma, Annamraju D., additional, Avalaskar, Nikhil, additional, LaForce, F. Marc, additional, Alderson, Mark R., additional, Naficy, Abdi, additional, Lamola, Steve, additional, Tang, Yuxiao, additional, Martellet, Lionel, additional, Hosken, Nancy, additional, Simeonidis, Evangelos, additional, Welsch, Jo Anne, additional, Tapia, Milagritos D., additional, and Clarke, Ed, additional

Published
2023
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11. Model-estimated impacts of pediatric respiratory syncytial virus prevention programs in Mali on asthma prevalence

Author

Ortiz, Justin R., primary, Laufer, Rachel S., additional, Brunwasser, Steven M., additional, Coulibaly, Flanon, additional, Diallo, Fatoumata, additional, Doumbia, Moussa, additional, Driscoll, Amanda J., additional, Fell, Deshayne B., additional, Haidara, Fadima C., additional, Hartert, Tina V., additional, Keita, Adama M., additional, Neuzil, Kathleen M., additional, Snyder, Brittney M., additional, Sow, Samba, additional, and Fitzpatrick, Meagan C., additional

Published
2023
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12. Cost-effectiveness of infant respiratory syncytial virus preventive interventions in Mali: A modeling study to inform policy and investment decisions

Author

Laufer, Rachel S., primary, Driscoll, Amanda J., additional, Baral, Ranju, additional, Buchwald, Andrea G., additional, Campbell, James D., additional, Coulibaly, Flanon, additional, Diallo, Fatoumata, additional, Doumbia, Moussa, additional, Galvani, Alison P., additional, Haidara, Fadima C., additional, Kotloff, Karen L., additional, Keita, Adama M., additional, Neuzil, Kathleen M., additional, Orenstein, Evan W., additional, Orenstein, Lauren A.V., additional, Pecenka, Clint, additional, Sow, Samba, additional, Tapia, Milagritos D., additional, Ortiz, Justin R., additional, and Fitzpatrick, Meagan C., additional

Published
2021
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13. Epidemiology, Risk Factors, and Outcomes of Respiratory Syncytial Virus Infections in Newborns in Bamako, Mali

Author

Buchwald, Andrea G, Tamboura, Boubou, Tennant, Sharon M, Haidara, Fadima C, Coulibaly, Flanon, Doumbia, Moussa, Diallo, Fatoumata, Keita, Adama M, Sow, Samba O, Kotloff, Karen L, Levine, Myron M, and Tapia, Milagritos D

Subjects
Male, viruses, Incidence, active surveillance, Infant, Newborn, virus diseases, RSV, Infant, Respiratory Syncytial Virus Infections, respiratory system, Mali, Hospitalization, Pregnancy, Risk Factors, Respiratory Syncytial Virus, Human, acute respiratory infection, pneumonia, Humans, Female, Articles and Commentaries
Abstract

Background Few studies describe the respiratory syncytial virus (RSV) burden in African populations, and most have utilized hospital-based surveillance. In Mali, no community-based studies exist of the incidence or epidemiology of RSV infection. This study provides the first estimates of RSV incidence in Mali. Methods In a cohort of infants enrolled in a clinical trial of maternal influenza vaccination, we estimate incidence of RSV-associated febrile illness in the first 6 months of life and identify risk factors for RSV infection and progression to severe disease. Infants (N = 1871) were followed from birth to 6 months of age and visited weekly to detect pneumonia and influenza-like illness. Baseline covariates were explored as risk factors for RSV febrile illness and RSV pneumonia or hospitalization. Results Incidence of RSV illness was estimated at 536.8 per 1000 person-years, and 86% (131/153) of RSV illness episodes were positive for RSV-B. RSV illness was most frequent in the fifth month of life and associated with having older mothers and with lower parity. The incidence of RSV-associated hospitalizations was 45.6 per 1000 person-years. Among infants with RSV illness, males were more likely to be hospitalized. The incidence of RSV pneumonia was 29 cases per 1000 person-years. Conclusions In the first 6 months of life, Malian infants have a high incidence of RSV illness, primarily caused by RSV-B. Prevention of early RSV will require passive protection via maternal immunization in pregnancy. Mali is the first country where RSV-B has been identified as the dominant subtype, with potential implications for vaccine development., This first report of community-based surveillance for respiratory syncytial virus (RSV) infection in Mali showed that RSV-B was the dominant subtype, in contrast to other regions. Incidence was high early in life, before infant vaccination is a viable strategy.

Published
2019

14. Maternal Influenza Vaccination and the Risk of Laboratory-Confirmed Influenza Among Household Contacts Under the Age of Five in Mali

Author

Buchwald, Andrea G., Tamboura, Boubou, Haidara, Fadima C., Coulibaly, Flanon, Doumbia, Moussa, Diallo, Fatoumata, Boudova, Sarah, Keita, Adama M., Sow, Samba O., Kotloff, Karen, Levine, Myron, and Tapia, Milagritos D.

Subjects
Adult, Male, Incidence, Vaccination, virus diseases, Infant, Mothers, Articles, Mali, Influenza A Virus, H1N1 Subtype, Influenza Vaccines, Pregnancy, Risk Factors, Child, Preschool, Influenza, Human, Humans, Family, Female
Abstract

Influenza transmission is increased among household contacts. Vaccination decreases transmission; however it is unclear how vaccinating a single individual alters disease risk among household contacts, particularly in regions with low vaccination coverage. Pregnant women were randomized to influenza or control vaccination. Households were visited weekly until infants born to enrolled women reached 6 months. Household contacts younger than 5 years were tested for laboratory-confirmed influenza (LCI). Incidence of LCI and rate ratios (RtR) comparing incidence between vaccine groups were calculated. The secondary infection rate (SIR) was calculated for households where LCI was detected. The H1N1 strain in the vaccine was a match for circulating H1N1 during the study, thus, all analyses were performed for H1N1-LCI and any LCI. A total of 5,345 household contacts younger than 5 years followed for a mean of 228 days (standard deviation [SD] = 45 days) experienced 2,957 influenza-like illness episodes. Incidence of any LCI and H1N1-LCI was 23 (N = 276) and 7.3 per 100,000 days (N = 89), respectively. Household contacts of women who received influenza vaccine had fewer LCI (RtR = 0.90; 95% CI: 0.71, 1.14) and fewer H1N1-LCI (RtR = 0.73; 95% CI: 0.48, 1.11) episodes than contacts in control households. Incidence of LCI and household SIR were low in households of women enrolled in an influenza vaccine trial in Mali. Although low incidence made statistical significance difficult to detect, there was a trend for decreased rates of H1N1-LCI in households where a pregnant mother received influenza vaccination.

Published
2018

15. Meningococcal Serogroup ACWYX Conjugate Vaccine in Malian Toddlers

Author

Tapia, Milagritos D., primary, Sow, Samba O., additional, Naficy, Abdi, additional, Diallo, Fatoumata, additional, Haidara, Fadima C., additional, Chaudhari, Amol, additional, Martellet, Lionel, additional, Traore, Awa, additional, Townsend-Payne, Kelly, additional, Borrow, Ray, additional, Hosken, Nancy, additional, Smolenov, Igor, additional, Pisal, Sambhaji S., additional, LaForce, F. Marc, additional, Dhere, Rajeev M., additional, Kapse, Dhananjay, additional, Tang, Yuxiao, additional, Alderson, Mark R., additional, and Kulkarni, Prasad S., additional

Published
2021
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16. Maternal Influenza Vaccination and the Risk of Laboratory-Confirmed Influenza Among Household Contacts Under the Age of Five in Mali

Author

Buchwald, Andrea G., primary, Tamboura, Boubou, additional, Haidara, Fadima C., additional, Coulibaly, Flanon, additional, Doumbia, Moussa, additional, Diallo, Fatoumata, additional, Boudova, Sarah, additional, Keita, Adama M., additional, Sow, Samba O., additional, Kotloff, Karen, additional, Levine, Myron, additional, and Tapia, Milagritos D., additional

Published
2019
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18. Epidemiology, Risk Factors, and Outcomes of Respiratory Syncytial Virus Infections in Newborns in Bamako, Mali.

Author

Buchwald, Andrea G, Tamboura, Boubou, Tennant, Sharon M, Haidara, Fadima C, Coulibaly, Flanon, Doumbia, Moussa, Diallo, Fatoumata, Keita, Adama M, Sow, Samba O, Kotloff, Karen L, Levine, Myron M, and Tapia, Milagritos D

Subjects
AGE distribution, FEVER, HOSPITAL care, INFLUENZA, MOTHERS, PUBLIC health surveillance, RISK assessment, SEX distribution, VIRAL pneumonia, DISEASE incidence, PARITY (Obstetrics), DISEASE progression, DESCRIPTIVE statistics, RESPIRATORY syncytial virus infections, DISEASE complications, DISEASE risk factors, CHILDREN
Abstract

Background Few studies describe the respiratory syncytial virus (RSV) burden in African populations, and most have utilized hospital-based surveillance. In Mali, no community-based studies exist of the incidence or epidemiology of RSV infection. This study provides the first estimates of RSV incidence in Mali. Methods In a cohort of infants enrolled in a clinical trial of maternal influenza vaccination, we estimate incidence of RSV-associated febrile illness in the first 6 months of life and identify risk factors for RSV infection and progression to severe disease. Infants (N = 1871) were followed from birth to 6 months of age and visited weekly to detect pneumonia and influenza-like illness. Baseline covariates were explored as risk factors for RSV febrile illness and RSV pneumonia or hospitalization. Results Incidence of RSV illness was estimated at 536.8 per 1000 person-years, and 86% (131/153) of RSV illness episodes were positive for RSV-B. RSV illness was most frequent in the fifth month of life and associated with having older mothers and with lower parity. The incidence of RSV-associated hospitalizations was 45.6 per 1000 person-years. Among infants with RSV illness, males were more likely to be hospitalized. The incidence of RSV pneumonia was 29 cases per 1000 person-years. Conclusions In the first 6 months of life, Malian infants have a high incidence of RSV illness, primarily caused by RSV-B. Prevention of early RSV will require passive protection via maternal immunization in pregnancy. Mali is the first country where RSV-B has been identified as the dominant subtype, with potential implications for vaccine development. [ABSTRACT FROM AUTHOR]

Published
2020
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19. Randomized, Placebo-Controlled, Double-Blind Phase 2 Trial Comparing the Reactogenicity and Immunogenicity of a Single Standard Dose to Those of a High Dose of CVD 103-HgR Live Attenuated Oral Cholera Vaccine, with Shanchol Inactivated Oral Vaccine as an Open-Label Immunologic Comparator

Author

Sow, Samba O., primary, Tapia, Milagritos D., additional, Chen, Wilbur H., additional, Haidara, Fadima C., additional, Kotloff, Karen L., additional, Pasetti, Marcela F., additional, Blackwelder, William C., additional, Traoré, Awa, additional, Tamboura, Boubou, additional, Doumbia, Moussa, additional, Diallo, Fatoumata, additional, Coulibaly, Flanon, additional, Onwuchekwa, Uma, additional, Kodio, Mamoudou, additional, Tennant, Sharon M., additional, Reymann, Mardi, additional, Lam, Diana F., additional, Gurwith, Marc, additional, Lock, Michael, additional, Yonker, Thomas, additional, Smith, Jonathan, additional, Simon, Jakub K., additional, and Levine, Myron M., additional

Published
2017
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20. Cost-effectiveness of maternal influenza immunization in Bamako, Mali: A decision analysis

Author

Orenstein, Evan W., primary, Orenstein, Lauren A. V., additional, Diarra, Kounandji, additional, Djiteye, Mahamane, additional, Sidibé, Diakaridia, additional, Haidara, Fadima C., additional, Doumbia, Moussa F., additional, Diallo, Fatoumata, additional, Coulibaly, Flanon, additional, Keita, Adama M., additional, Onwuchekwa, Uma, additional, Teguete, Ibrahima, additional, Tapia, Milagritos D., additional, Sow, Samba O., additional, Levine, Myron M., additional, and Rheingans, Richard, additional

Published
2017
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21. Efficacy of the oral pentavalent rotavirus vaccine in Mali

Author

Sow, Samba O., primary, Tapia, Milagritos, additional, Haidara, Fadima C., additional, Ciarlet, Max, additional, Diallo, Fatoumata, additional, Kodio, Mamoudou, additional, Doumbia, Moussa, additional, Dembélé, Rokiatou D., additional, Traoré, Oumou, additional, Onwuchekwa, Uma U., additional, Lewis, Kristen D.C., additional, Victor, John C., additional, Steele, A. Duncan, additional, Neuzil, Kathleen M., additional, Kotloff, Karen L., additional, and Levine, Myron M., additional

Published
2012
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22. Randomized, Placebo-Controlled, Double-Blind Phase 2 Trial Comparing the Reactogenicity and Immunogenicity of a Single Standard Dose to Those of a High Dose of CVD 103-HgR Live Attenuated Oral Cholera Vaccine, with Shanchol Inactivated Oral Vaccine as an Open-Label Immunologic Comparator

Author

Sow, Samba O., Tapia, Milagritos D., Chen, Wilbur H., Haidara, Fadima C., Kotloff, Karen L., Pasetti, Marcela F., Blackwelder, William C., Traoré, Awa, Tamboura, Boubou, Doumbia, Moussa, Diallo, Fatoumata, Coulibaly, Flanon, Onwuchekwa, Uma, Kodio, Mamoudou, Tennant, Sharon M., Reymann, Mardi, Lam, Diana F., Gurwith, Marc, Lock, Michael, Yonker, Thomas, Smith, Jonathan, Simon, Jakub K., and Levine, Myron M.

Abstract

ABSTRACTReactive immunization with a single-dose cholera vaccine that could rapidly (within days) protect immunologically naive individuals during virgin soil epidemics, when cholera reaches immunologically naive populations that have not experienced cholera for decades, would facilitate cholera control. One dose of attenuated Vibrio choleraeO1 classical Inaba vaccine CVD 103-HgR (Vaxchora) containing =2 × 108CFU induces vibriocidal antibody seroconversion (a correlate of protection) in >90% of U.S. adults. A previous CVD 103-HgR commercial formulation required =2 × 109CFU to elicit high levels of seroconversion in populations in developing countries. We compared the vibriocidal responses of Malians (individuals 18 to 45 years old) randomized to ingest a single =2 × 108-CFU standard dose (n= 50) or a =2 × 109-CFU high dose (n= 50) of PaxVax CVD 103-HgR with buffer or two doses (n= 50) of Shanchol inactivated cholera vaccine (the immunologic comparator). To maintain blinding, participants were dosed twice 2 weeks apart; CVD 103-HgR recipients ingested placebo 2 weeks before or after ingesting vaccine. Seroconversion (a =4-fold vibriocidal titer rise) between the baseline and 14 days after CVD 103-HgR ingestion and following the first and second doses of Shanchol were the main outcomes measured. By day 14 postvaccination, the rates of seroconversion after ingestion of a single standard dose and a high dose of CVD 103-HgR were 71.7% (33/46 participants) and 83.3% (40/48 participants), respectively. The rate of seroconversion following the first dose of Shanchol, 56.0% (28/50 participants), was significantly lower than that following the high dose of CVD 103-HgR (P= 0.003). The vibriocidal geometric mean titer (GMT) of the high dose of CVD 103-HgR exceeded the GMT of the standard dose at day 14 (214 versus 95, P= 0.045) and was ~2-fold higher than the GMT on day 7 and day 14 following the first Shanchol dose (P> 0.05). High-dose CVD 103-HgR is recommended for accelerated evaluation in developing countries to assess its efficacy and practicality in field situations. (This study has been registered at ClinicalTrials.gov under registration no. NCT02145377.)

Published
2018
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