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

• Published in: Vaccine Vol. 32; no. 44; pp. 5801 - 5808
• Main Authors: Njuguna, Irene N, Ambler, Gwen, Reilly, Marie, Ondondo, Beatrice, Kanyugo, Mercy, Lohman-Payne, Barbara, Gichuhi, Christine, Borthwick, Nicola, Black, Antony, Mehedi, Shams-Rony, Sun, Jiyu, Maleche-Obimbo, Elizabeth, Chohan, Bhavna, John-Stewart, Grace C, Jaoko, Walter, Hanke, Tomáš
• Format: Journal Article
• Language: English
• Published: Kidlington Elsevier Ltd 07-10-2014; Elsevier; Elsevier Limited; Elsevier Science
• Subjects: Adult; AIDS Vaccines - therapeutic use; Allergy and Immunology; Anti-HIV Agents - therapeutic use; Antiretroviral agents; Applied microbiology; Biological and medical sciences; Breast feeding; EPI vaccines; Exposed-uninfected infants; Female; Fundamental and applied biological sciences. Psychology; Hepatitis B virus; HIV; HIV Antibodies - blood; HIV Infections - drug therapy; HIV Infections - prevention & control; HIV-1; Human immunodeficiency virus; Human immunodeficiency virus 1; Humans; Immunization; Immunogenicity; Infant; Infant vaccine trial in Africa; Infants; Infectious Disease Transmission, Vertical - prevention & control; Interferon-gamma - immunology; Kenya; KEPI vaccines; Male; Medicin och hälsovetenskap; Microbiology; Miscellaneous; Modified vaccinia virus Ankara (MVA); Mothers; Pediatric HIV-1 vaccines; Pregnancy; Pregnancy Complications, Infectious - immunology; Prophylaxis; Safety; T-Lymphocytes - immunology; Vaccines; Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies (general aspects); Vaccines, DNA; Virology; Womens health; Young Adult; Africa; Kenya; HIV-1; ART; KNH; tenofovir; antiretroviral therapy; hepatitis B virus; NVP; Dtx; recombinant modified vaccinia virus Ankara; Hemophilus influenzae type b; interquartile range; human immunodeficiency virus type 1; HIV-1-exposed uninfected; WAZ; nevirapine; EFV; OPV; Exposed-uninfected infants; TDF; Ttx; Kenyatta National Hospital; KEPI vaccines; HBV; efavirenz; lopinavir/ritonavir; Hib; 3TC; PMTCT; zidovudine; tetanus toxin (Ttx); IQR; ZDV; KEPI; rMVA; EPI vaccines; oral polio vaccine; Kenyan Expanded Program on Immunization; weight-for-age Z-score; LPV/RTV; diphtheria toxin; HEU; Infant vaccine trial in Africa; Pediatric HIV-1 vaccines; Modified vaccinia virus Ankara (MVA); prevention of mother-to-child transmission of HIV-1; lamivudine; Human; Chordopoxvirinae; HIV-1 virus; Orthopoxvirus; Retroviridae; Infant; Vaccine; Lentivirus; Virus; Vaccinia virus; Poxviridae; Phase II trial; Phase I trial; Human immunodeficiency virus
• ISSN: 0264-410X; 1873-2518; 1873-2518
• DOI: 10.1016/j.vaccine.2014.08.034

Highlights • MVA.HIVA vaccine was tested for the first time in HIV-1-exposed infants in Africa. • PedVacc 002 had 99% retention of infants over 48 weeks of follow-up. • MVA.HIVA was safe, but not sufficiently immunogenic. • MVA.HVA did not interfere with routine childhood vaccines except for induction of HBV antibodies. • MVA is well suited as a vaccine vector for infants under 1 year of age.