Three doses of a rotavirus vaccine were well tolerated by a group of
infants with HIV, according to results of a study published online.
Andrew Duncan Steele, PhD, and colleagues of WHO reported on a
group of 100 infants who were randomly assigned to receive the vaccine RIX4414
The researchers noted similar incidences of symptoms, as well as
comparable rates of mean absolute CD4 counts, and viral load. Adverse events
were also similar in both groups, with six fatal serious adverse events in the
vaccine group and nine in the placebo group. Seroconversion rates were 57.1%
(95% CI, 34-78.2) in the RIX4414 group and 18.2% (95% CI, 5.2-40.3) in the
The researchers said rotavirus shedding peaked at day 7 after the first
rotavirus vaccine dose.
Current WHO recommendations call for physicians to use their discretion
when immunizing babies who are immunocompromised against rotavirus; however, in
South Africa, where many women get their health care in antenatal clinics, this
strategy may be less practical, according to the researchers.
“This study supports rotavirus vaccination in HIV-positive infants
as it demonstrates good immunogenicity with no safety issues,” they said.
Disclosures: The research was supported by grants from WHO, PATH,
the Norwegian Program for Development, Research and Higher Education research
grant (PRO 48/2002), and the South African Medical Research Council.
GlaxoSmithKline Biologicals provided funding.
Rotavirus is the leading cause of diarrhea in infants and young children across the world and is an important cause of hospitalization and death, especially in resource-limited countries. HIV-infected infants acquire rotavirus at the same frequency as uninfected infants but may have more severe disease if there are concurrent nutritional deficiencies or opportunistic infections. Effective vaccines for rotavirus will have major health benefits. At present, the WHO recommends that rotavirus vaccine be administered during early infancy so that immunization will often precede determination of HIV infection status. However, there are few data on the safety and immunogenicity of rotavirus vaccines in HIV-infected infants.
This study provides additional evidence of the safety of this vaccine. The vaccinated cohort had no evidence of increased rate of CD4 decline, which is relevant to the concern that vaccine administration could accelerate HIV disease progression. A question not addressed in this study is whether administration of an oral live-virus vaccine to uninfected infants exposed to HIV through breast-feeding might result in increased risk of post-natal HIV acquisition. This study supports the safety of administration of rotavirus vaccine to HIV-infected infants and demonstrates immunogenicity that is comparable to HIV-uninfected infants living in the same country.
It will be important to conduct additional studies of other rotavirus vaccines as well as studies that evaluate rates of HIV acquisition in breast-fed infants.
– Elizabeth McFarland, MD
Pediatric Infectious Diseases,
University of Colorado Denver Health Sciences Center
Diclosure: Dr. McFarland reports no relevant financial disclosures.