PedVacc 002: A phase I/II randomized clinical trial of MVA.HIVA vaccine administered to infants born to human immunodeficiency virus type 1-positive mothers in Nairobi
![Thumbnail](/bitstream/handle/11295/74582/PedVacc%20002%3a%20A%20phase%20I/II%20randomized%20clinical%20trial.pdf.jpg?sequence=4&isAllowed=y)
View/ Open
Date
2014-10Author
Njuguna, Irene N
Ambler, Gwen
Reilly, Marie
Ondondo, Beatrice
Kanyugo, Mercy
Lohman-Payne, Barbara
Gichuhie, Christine
Borthwick, Nicola
Black, Antony
Mehedi, Shams-Rony
Sun, Jiyu
Maleche-Obimbo, Elizabeth
Chohan, Bhavna
John-Stewart, Grace C
Jaoko, Walter
Hanke, Tomáš
Language
enMetadata
Show full item recordAbstract
Background
A safe, effective vaccine for breastfeeding infants born to HIV-1-positive mothers could complement antiretroviral therapy (ART) for prevention of mother-to-child transmission of HIV-1. To date, only a few HIV-1 vaccine candidates have been tested in infants.
Trial design
A phase I/II randomized controlled trial PedVacc 002 was conducted to determine the safety and immunogenicity of a single, low dose of MVA.HIVA vaccine delivered intramuscularly to healthy 20-week-old infants born to HIV-1-positive mothers in Nairobi, Kenya.
Methods
Pregnant HIV-1-positive women in the 2nd/3rd trimester of gestation were enrolled, provided with ART and self-selected their infant-feeding modality. Infants received nevirapine and cotrimoxazole prophylaxis. At 20 weeks of age, eligible HIV-1-negative infants were randomized to vaccine versus no-treatment arms and followed to 48 weeks of age for assessments of vaccine safety, HIV-1-specific T-cell responses and antibodies to routine childhood vaccines.
Results
Between February and November 2010, 182 mothers were screened, 104 were eligible and followed on ART during pregnancy/postpartum, of whom 73 had eligible infants at 20 weeks postpartum. Thirty-six infants were randomized to vaccine and 37 to no treatment. Eighty-four percent of infants breastfed, and retention at 48 weeks was 99%. Adverse events were rare and similar between the two arms. HIV-1-specific T-cell frequencies in interferon-γ ELISPOT assay were transiently higher in the MVA.HIVA arm (p = 0.002), but not above the threshold for a positive assay. Protective antibody levels were adequate and similar between arms for all routine childhood vaccines except HBV, where 71% of MVA.HIVA subjects compared to 92% of control subjects were protected (p = 0.05).
Conclusions
This trial tested for the first time an MVA-vectored candidate HIV-1 vaccine in HIV-1-exposed infants in Africa, demonstrating trial feasibility and vaccine safety, low immunogenicity, and compatibility with routine childhood vaccinations. These results are reassuring for use of the MVA vector in more potent prime-boost regimens.
URI
http://hdl.handle.net/11295/74582http://www.sciencedirect.com/science/article/pii/S0264410X14011578
Citation
Volume 32, Issue 44, 7 October 2014, Pages 5801–5808Publisher
University of Nairobi
Collections
- Faculty of Health Sciences (FHS) [10385]
Related items
Showing items related by title, author, creator and subject.
-
HIV vaccine Update: Phase I and II vaccine trials at the Kenya AIDS Vaccine Initiative
Jaoko, WG (University of NairobiSchool of Medicine, 2004) -
Safety and Immunogenicity Study of Multiclade HIV-1 Adenoviral Vector Vaccine Alone or as Boost following a Multiclade HIV-1 DNA Vaccine in Africa
Anzala, Aggrey O.; Jaoko Walter G.; Karita, E.; Kayitenkore, K.; Than, S.; Adams, EM.; Graham, BS.; Koup, RA.; Bailer, RT.; Smith, C.; Dally, L.; Farah, B.; Muvunyi, CM.; Bizimana, J.; Tarragona-Fiol, T.; Bergin, PJ.; Hayes, P.; Ho, M.; Loughran, K.; Komaroff, W.; Stevens, G.; Thomson, H.; Boaz, MJ.; Cox, JH.; Schmidt, C.; Gilmour, J.; Nabel, GJ.; Fast, P. (University of nairobiCollege of health science, 2010)Abstract BACKGROUND: We conducted a double-blind, randomized, placebo-controlled Phase I study of a recombinant replication-defective adenovirus type 5 (rAd5) vector expressing HIV-1 Gag and Pol from subtype B and Env ... -
Safety and immunogenicity of DNA and MVA HIVA vaccines in Phase-1 vaccine trials in Nairobi, Kenya
Jaoko, WG; Omosa, G; Bhatt, K; Matu, L; Ogutu, H; Wakasiaka, S; Odada, J; Anzala, O; Bashir, F; Oyaro, M; Indangasi, J; Ndinya-Achola, J; Schmidt, C; Hanke, T; McMichael, A; Fast, P; Bwayo, J (University of NairobiSchool of Medicine, 2004)