HIV Vaccine Administration Routes: Safety and Immunogenicity Study
Author Information
Author(s): Koblin Beryl A., Casapia Martin, Morgan Cecilia, Qin Li, Wang Zhixue Maggie, Defawe Olivier D., Baden Lindsey, Goepfert Paul, Tomaras Georgia D., Montefiori David C., McElrath M. Juliana, Saavedra Lilian, Lau Chuen-Yen, Graham Barney S.
Primary Institution: The NIAID HIV Vaccine Trials Network
Hypothesis
Does the route of administration affect the safety and immunogenicity of an HIV vaccine?
Conclusion
The study found no significant differences in immunogenicity by route of administration, despite higher local reactions with intradermal and subcutaneous routes.
Supporting Evidence
- The study involved 90 participants randomized into three groups based on the route of administration.
- Significant differences in local reactions were observed, with higher rates of headache and pain in the SC group.
- Immunogenicity was measured through various assays, showing no significant differences among the administration routes.
Takeaway
This study tested different ways to give an HIV vaccine to see if it would work better or cause more side effects. It found that changing how the vaccine is given didn't make it work better.
Methodology
A multicenter, open-label, randomized trial comparing intramuscular, intradermal, and subcutaneous routes of administration for an HIV vaccine.
Potential Biases
Participants and staff were not blinded to group assignment, which may introduce bias.
Limitations
The study was limited by a reduced sample size due to the suspension of vaccinations after the Step Study results.
Participant Demographics
90 healthy, HIV-1 uninfected adults aged 18-50, with 41% women, 40% non-Hispanic Whites, 32% Hispanic, and 18% non-Hispanic Black.
Statistical Information
P-Value
p=0.01 for headache severity, p=0.04 for pain, p<0.0001 for erythema/induration
Confidence Interval
95% CI: 43.7, 83.7 for IM group; 95% CI: 48.1, 85.5 for ID group; 95% CI: 54.8, 91.0 for SC group
Statistical Significance
p<0.05
Digital Object Identifier (DOI)
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