Back to Search
Start Over
Flexibility of interval between vaccinations with AS03A-adjuvanted influenza A (H1N1) 2009 vaccine in adults aged 18–60 and >60 years: a randomized trial
- Source :
- BMC Infectious Diseases, Vol 12, Iss 1, p 162 (2012), BMC Infectious Diseases, BMC Infectious Diseases, BioMed Central, 2012, 12 (1), pp.162. ⟨10.1186/1471-2334-12-162⟩, BMC Infectious Diseases (12), . (2012)
- Publication Year :
- 2012
- Publisher :
- BMC, 2012.
-
Abstract
- Background Flexibility of vaccination schedule and lower antigen content can facilitate pandemic vaccine coverage. We assessed the immune response and safety of AS03-adjuvanted A/California/7/2009 H1N1 pandemic vaccine containing half of the registered adult haemagglutinin (HA) antigen content, administered as a two-dose schedule at intervals of 21 days or 6 months in both young and elderly adults. Methods In this open-label randomized trial, healthy adults aged 18–60 years (N = 163) and >60 years (N = 143) received AS03A-adjuvanted A/California/7/2009 H1N1 vaccine containing 1.9 μg HA on Day 0. A second dose was given on Day 21 (n = 177) or Day 182 (n = 106). Haemagglutination-inhibition (HI) antibody responses were analyzed on Days 0, 21, 42, 182, 364 and additionally on Day 203 for subjects vaccinated on Day 182. Solicited and unsolicited adverse events were recorded. Results The HI antibody response in both age strata 21 days after the first dose met and exceeded all regulatory acceptance criteria although the results suggested a lower response in the older age stratum (geometric mean titres [GMTs] for HI antibodies of 420.5 for subjects aged 18–60 years and 174.4 for those >60 years). A second dose of AS03A adjuvanted A/H1N1/2009 vaccine induced a further increase in antibody titres and the response was similar whether the second dose was administered at 21 days (GMTs of 771.8 for 18–60 years and 400.9 for >60 years) or 6 months (GMTs of 708.3 for 18–60 years and 512.1 for >60 years) following the first dose. Seroprotection rates remained high at 6 months after one dose or two doses while at 12 months rates tended to be higher for the 6 month interval schedule (93.3% for 18–60 years and 80.4% for >60 years) than the 21 day schedule (82.3% for 18–60 years and 50.0% for >60 years). Reactogenicity/safety profiles were similar for both schedules, there was no evidence of an increase in reactogenicity following the second dose. Conclusions The results indicate that flexibility in the dosing interval for AS03A adjuvanted vaccine may be possible. Such flexibility could help to reduce the logistic stress on delivery of pandemic vaccination programmes. Trial registration ClinicalTrials.gov, NCT00975884
- Subjects :
- Male
Time Factors
Vaccination schedule
medicine.disease_cause
Antibodies, Viral
IMMUNOGENICITY
law.invention
0302 clinical medicine
Influenza A Virus, H1N1 Subtype
Randomized controlled trial
law
[SDV.MHEP.MI]Life Sciences [q-bio]/Human health and pathology/Infectious diseases
CROSS-PROTECTION
AS03 ADJUVANT
VIRUS
RESPONSES
SAFETY
IMMUNITY
PROFILE
Influenza A virus
030212 general & internal medicine
Young adult
Vaccination
Age Factors
Middle Aged
3. Good health
Infectious Diseases
Influenza Vaccines
[SDV.MHEP.MI] Life Sciences [q-bio]/Human health and pathology/Infectious diseases
Female
Research Article
Adult
medicine.medical_specialty
Adolescent
030231 tropical medicine
lcsh:Infectious and parasitic diseases
03 medical and health sciences
Young Adult
Antigen
Adjuvants, Immunologic
Internal medicine
Influenza, Human
medicine
Humans
lcsh:RC109-216
Adverse effect
Immunization Schedule
Reactogenicity
business.industry
Hemagglutination Inhibition Tests
Immunology
business
Subjects
Details
- Language :
- English
- ISSN :
- 14712334
- Volume :
- 12
- Issue :
- 1
- Database :
- OpenAIRE
- Journal :
- BMC Infectious Diseases
- Accession number :
- edsair.doi.dedup.....8a76e53f12d6e101e30556444d8e9d6c