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Immunogenicity of the pentavalent rotavirus vaccine in African infants.
Vaccine. 2012 Apr 27; 30 Suppl 1:A86-93.V

Abstract

We recently completed a double-blind, placebo-controlled, multicenter Phase III clinical trial of the pentavalent rotavirus vaccine (PRV) in three African countries, Ghana, Kenya, and Mali, from April 2007 to March 2009. The immunogenicity of PRV in African infants is described. In total, 5468 infants were randomized 1:1 to receive 3 doses of PRV or placebo at approximately 6, 10, and 14 weeks of age. Breastfeeding and concomitant administration of EPI vaccines, including OPV, were allowed, and HIV-infected infants were not excluded. Immunogenicity of PRV was assessed by measuring serum anti-rotavirus IgA responses, as well as serum neutralization antibody (SNA) to the human rotavirus serotypes G1, G2, G3, G4 and P1A[8] in approximately 150 infants per country. Sera were collected pre-dose 1 (pD1) and approximately 14 days post-dose 3 (PD3) for immunological analysis. For the sero-response rates (≥ 3-fold rise from pD1 to PD3), the number of subjects evaluable included those with both pD1 and PD3 data available. PRV was immunogenic in African children and significantly reduced severe RVGE in African children through the first two years of life. The pooled anti-rotavirus IgA sero-response rate was 78.3%, with consistent rates in each of the African sites: 73.8% (Kenya), 78.9% (Ghana), and 82.5% (Mali); but generally lower than that reported in Europe and USA. PD3 GMTs (28.2 dilution-units) were 5-10 times lower than those assessed in subjects in clinical trials in developed countries. SNA responses to human rotavirus serotypes G1-G4 and P1A[8] ranged from 6.3% (G3) to 26.5% (G4). PD3 SNA GMTs to G1 and P1A[8] were 4-fold and 3-fold lower respectively, when compared to the corresponding GMTs in subjects who received PRV in similar studies conducted in developed countries. PRV was immunogenic in African infants, and the anti-rotavirus IgA sero-response rates were similar across all three African sites although lower than those observed in Europe and USA. While immune correlates of protection have not been established for rotavirus, the findings are consistent with lower efficacy rates demonstrated during this trial. Further investigation is needed to understand the reason for the lower immunogenicity observed.

Authors+Show Affiliations

Noguchi Memorial Institute for Medical Research, College of Health Sciences, University of Ghana, Legon, Ghana.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase III
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

22520142

Citation

Armah, George E., et al. "Immunogenicity of the Pentavalent Rotavirus Vaccine in African Infants." Vaccine, vol. 30 Suppl 1, 2012, pp. A86-93.
Armah GE, Breiman RF, Tapia MD, et al. Immunogenicity of the pentavalent rotavirus vaccine in African infants. Vaccine. 2012;30 Suppl 1:A86-93.
Armah, G. E., Breiman, R. F., Tapia, M. D., Dallas, M. J., Neuzil, K. M., Binka, F. N., Sow, S. O., Ojwando, J., Ciarlet, M., & Steele, A. D. (2012). Immunogenicity of the pentavalent rotavirus vaccine in African infants. Vaccine, 30 Suppl 1, A86-93. https://doi.org/10.1016/j.vaccine.2011.10.006
Armah GE, et al. Immunogenicity of the Pentavalent Rotavirus Vaccine in African Infants. Vaccine. 2012 Apr 27;30 Suppl 1:A86-93. PubMed PMID: 22520142.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Immunogenicity of the pentavalent rotavirus vaccine in African infants. AU - Armah,George E, AU - Breiman,Robert F, AU - Tapia,Milagritos D, AU - Dallas,Michael J, AU - Neuzil,Kathleen M, AU - Binka,Fred N, AU - Sow,Samba O, AU - Ojwando,Joel, AU - Ciarlet,Max, AU - Steele,A Duncan, PY - 2011/07/20/received PY - 2011/09/01/revised PY - 2011/10/03/accepted PY - 2012/4/24/entrez PY - 2012/5/2/pubmed PY - 2012/8/9/medline SP - A86 EP - 93 JF - Vaccine JO - Vaccine VL - 30 Suppl 1 N2 - We recently completed a double-blind, placebo-controlled, multicenter Phase III clinical trial of the pentavalent rotavirus vaccine (PRV) in three African countries, Ghana, Kenya, and Mali, from April 2007 to March 2009. The immunogenicity of PRV in African infants is described. In total, 5468 infants were randomized 1:1 to receive 3 doses of PRV or placebo at approximately 6, 10, and 14 weeks of age. Breastfeeding and concomitant administration of EPI vaccines, including OPV, were allowed, and HIV-infected infants were not excluded. Immunogenicity of PRV was assessed by measuring serum anti-rotavirus IgA responses, as well as serum neutralization antibody (SNA) to the human rotavirus serotypes G1, G2, G3, G4 and P1A[8] in approximately 150 infants per country. Sera were collected pre-dose 1 (pD1) and approximately 14 days post-dose 3 (PD3) for immunological analysis. For the sero-response rates (≥ 3-fold rise from pD1 to PD3), the number of subjects evaluable included those with both pD1 and PD3 data available. PRV was immunogenic in African children and significantly reduced severe RVGE in African children through the first two years of life. The pooled anti-rotavirus IgA sero-response rate was 78.3%, with consistent rates in each of the African sites: 73.8% (Kenya), 78.9% (Ghana), and 82.5% (Mali); but generally lower than that reported in Europe and USA. PD3 GMTs (28.2 dilution-units) were 5-10 times lower than those assessed in subjects in clinical trials in developed countries. SNA responses to human rotavirus serotypes G1-G4 and P1A[8] ranged from 6.3% (G3) to 26.5% (G4). PD3 SNA GMTs to G1 and P1A[8] were 4-fold and 3-fold lower respectively, when compared to the corresponding GMTs in subjects who received PRV in similar studies conducted in developed countries. PRV was immunogenic in African infants, and the anti-rotavirus IgA sero-response rates were similar across all three African sites although lower than those observed in Europe and USA. While immune correlates of protection have not been established for rotavirus, the findings are consistent with lower efficacy rates demonstrated during this trial. Further investigation is needed to understand the reason for the lower immunogenicity observed. SN - 1873-2518 UR - https://www.unboundmedicine.com/medline/citation/22520142/Immunogenicity_of_the_pentavalent_rotavirus_vaccine_in_African_infants_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0264-410X(11)01600-8 DB - PRIME DP - Unbound Medicine ER -