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Safety and Immunogenicity of Different Formulations of a Tetravalent Dengue Purified Inactivated Vaccine in Healthy Adults from Puerto Rico: Final Results after 3 Years of Follow-Up from a Randomized, Placebo-Controlled Phase I Study
- Source :
- The American Journal of Tropical Medicine and Hygiene
- Publication Year :
- 2020
- Publisher :
- American Society of Tropical Medicine and Hygiene, 2020.
-
Abstract
- Four formulations of an investigational tetravalent dengue purified inactivated vaccine, administered as two doses one month (M) apart, were previously shown to be immunogenic and well-tolerated up to M13 of the phase I study NCT01702857. Here, we report results of the follow-up from M14 to year (Y) 3. One hundred healthy Puerto Rican adults, predominantly dengue virus (DENV)–primed, were randomized 1:1:1:1:1 to receive placebo or vaccine formulations: 1 μg/serotype/dose adjuvanted with aluminum, AS01E or AS03B, or aluminum-adjuvanted 4 μg/serotype/dose. No serious adverse events occurred. Two medically-attended potential immune-mediated disease cases, vaccination unrelated, were reported (groups 1 µg+Alum and 1 µg+AS03B). Of 14 instances of suspected dengue, none were laboratory confirmed. Geometric mean neutralizing antibody titers against DENV 1-4 waned from M14, but remained above pre-vaccination levels for DENV 1-3, with the highest values for group 1 µg+AS03B: 1220.1, 920.5, 819.4, and 940.5 (Y2), and 1329.3, 1169.2, 1219.8, and 718.9 (Y3). All formulations appeared to be safe and immunogenic during the 3-year follow-up.
- Subjects :
- Adult
Male
Serotype
030231 tropical medicine
Dengue Vaccines
Dengue virus
Antibodies, Viral
Placebo
medicine.disease_cause
Dengue fever
Dengue
03 medical and health sciences
0302 clinical medicine
Virology
Humans
Medicine
Neutralizing antibody
biology
business.industry
Immunogenicity
Puerto Rico
Articles
Dengue Virus
medicine.disease
Antibodies, Neutralizing
Vaccination
Infectious Diseases
Inactivated vaccine
biology.protein
Female
Parasitology
business
Follow-Up Studies
Subjects
Details
- ISSN :
- 14761645 and 00029637
- Volume :
- 102
- Database :
- OpenAIRE
- Journal :
- The American Journal of Tropical Medicine and Hygiene
- Accession number :
- edsair.doi.dedup.....4fe0676ffedccab546eaacc8857f86a2