advanced search

<< Back To Home

IMMUNOGENICITY OF ORAL LIVE ATTENUATED HUMAN ROTAVIRUS VACCINE GIVEN AS TWO DOSES (10 AND 14 WEEKS) IN HIV-INFECTED, HIV-EXPOSED-UNINFECTED AND HIV-UNEXPOSED-UNINFECTED INFANTS IN SOUTH AFRICA

Wednesday, 25th of July 2012

• IMMUNOGENICITY OF ORAL LIVE ATTENUATED HUMAN ROTAVIRUS VACCINE GIVEN AS TWO DOSES (10 AND 14 WEEKS) IN HIV-INFECTED, HIV-EXPOSED-UNINFECTED AND HIV-UNEXPOSED-UNINFECTED INFANTS IN SOUTH AFRICA

A. Koen¹, L. Jose¹, N. Govender¹, C. Cutland¹, F. Shafi², N. François³, J.P. Yarzabal³, M. Hezareh³, M. Moreira³, D. Borys³, L. Schuerman³, S.A. Madhi<sup>1,4

1</sup>University of the Witwatersrand, Medical Research Council, Respiratory and Meningeal Pathogens Research Unit and Department of Science and Technology/National Research Foundation, Vaccine Preventable Diseases, Johannesburg, South Africa, ²GlaxoSmithKline Pharmaceuticals, Bangalore, India, ³GlaxoSmithKline Biologicals, Wavre, Belgium, ⁴National Institute for Communicable Diseases (NICD) of the National Health Laboratory Service (NHLS), Center for Vaccines and Immunology, Johannesburg, South Africa

Also accessible at http://pag.aids2012.org/abstracts.aspx?aid=21226

Background: HIV-infected (HIV+) infants are at increased risk of diarrheal associated morbidity and mortality. There are limited published data on immune responses to rotavirus vaccines in HIV+ infants, and none in relation to a two-dose schedule of oral live attenuated human rotavirus vaccine (HRV, GlaxoSmithKline Biologicals). We evaluated the immune responses to HRV in HIV+, HIV-exposed-uninfected (HEU) and HIV-unexposed-uninfected (HUU) infants following two doses of HRV when given concurrently with 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV, GlaxoSmithKline Biologicals) and other recommended childhood vaccines.

Methods: In a phase III, open-label, single-center, controlled trial (NCT00829010) in South Africa, HIV+, HEU and HUU infants received two or three primary PHiD-CV doses at 6, (10), 14 weeks of age. After study start rotavirus vaccination was included in the South-African immunization program; HRV was therefore added as a study vaccine (through protocol amendment) and given at 10, 14 weeks of age. Sera were analyzed for anti-rotavirus IgA pre-vaccination and one month following the second HRV dose. HIV+ infants were managed with triple antiretroviral therapy per national guidelines.
Results: Of 446 infants (72 HIV+; 90 HEU; 284 HUU) in the according-to-protocol immunogenicity cohort (based on PHiD-CV vaccination), 327 received two HRV doses. An increase in anti-rotavirus IgA seropositivity rates (concentration ≥20 U/mL) and geometric mean concentrations (GMCs) was observed from pre- to post-vaccination in all three groups (Table). The post-vaccination seropositivity rate appeared lower in HIV+ (58.3%) than HUU subjects (71.9%) as did the post-vaccination antibody GMC (52.1 U/mL in HIV+ compared to 99.9 U/mL in HUU).



[Table]


Conclusions: Post-vaccination anti-rotavirus IgA concentrations and seropositivity rates tended to be lower in HIV+ infants than in HUU infants. The immunogenicity results were in line with those following a three-dose primary series of HRV in HIV+ infants from a previous study (NCT00263666).

Funding: GlaxoSmithKline Biologicals