BACKGROUND: The development of a safe and effective vaccine against HIV type 1 for the prevention of mother-to-child transmission of HIV would significantly advance the goal of eliminating HIV infection in children. Safety and feasibility results from phase 1, randomized, double-blind, placebo-controlled trial of ALVAC-HIV vCP1521 in infants born to HIV type1-infected women in Uganda are reported. METHODS:HIV-exposed infants were enrolled at birth and randomized (4:1) to receivevaccine or saline placebo intramuscular injections at birth, 4, 8, and 12 weeks of age. Vaccine reactogenicity was assessed at vaccination and days 1 and 2 postvaccination. Infants were followed until 24 months of age. HIV infection status was determined by HIV DNA polymerase chain reaction. RESULTS:From October 2006 to May 2007, 60 infants (48 vaccine and 12placebo) were enrolled with 98% retention at 24 months. One infant was withdrawn, but there were no missed visits or vaccinations among the 59 infants retained. Immune responses elicited by diphtheria, polio, hepatitis B, haemophilus influenzae type B, and measles vaccination were similar in the 2 arms. The vaccine was well tolerated with no severe or life-threatening reactogenicity events. Adverse events were equally distributed across both study arms. Four infants were diagnosed as HIV infected [3 at birth (2 vaccine and 1 placebo) and 1 in vaccine arm at 2 weeks of age]. CONCLUSION: The ALVAC-HIV vCP1521 vaccination was feasible and safe in infants born to HIV-infected women in Uganda. The conduct of high-quality infant HIV vaccine trials is achievable in Africa.
RCT Entities:
BACKGROUND: The development of a safe and effective vaccine against HIV type 1 for the prevention of mother-to-child transmission of HIV would significantly advance the goal of eliminating HIV infection in children. Safety and feasibility results from phase 1, randomized, double-blind, placebo-controlled trial of ALVAC-HIV vCP1521 in infants born to HIV type 1-infectedwomen in Uganda are reported. METHODS:HIV-exposed infants were enrolled at birth and randomized (4:1) to receive vaccine or saline placebo intramuscular injections at birth, 4, 8, and 12 weeks of age. Vaccine reactogenicity was assessed at vaccination and days 1 and 2 postvaccination. Infants were followed until 24 months of age. HIV infection status was determined by HIV DNA polymerase chain reaction. RESULTS: From October 2006 to May 2007, 60 infants (48 vaccine and 12 placebo) were enrolled with 98% retention at 24 months. One infant was withdrawn, but there were no missed visits or vaccinations among the 59 infants retained. Immune responses elicited by diphtheria, polio, hepatitis B, haemophilus influenzae type B, and measles vaccination were similar in the 2 arms. The vaccine was well tolerated with no severe or life-threatening reactogenicity events. Adverse events were equally distributed across both study arms. Four infants were diagnosed as HIV infected [3 at birth (2 vaccine and 1 placebo) and 1 in vaccine arm at 2 weeks of age]. CONCLUSION: The ALVAC-HIV vCP1521 vaccination was feasible and safe in infants born to HIV-infectedwomen in Uganda. The conduct of high-quality infantHIV vaccine trials is achievable in Africa.
Authors: Kalpana Gupta; Michael Hudgens; Lawrence Corey; M Juliana McElrath; Kent Weinhold; David C Montefiori; Geoffrey J Gorse; Sharon E Frey; Michael C Keefer; Thomas G Evans; Raphael Dolin; David H Schwartz; Clayton Harro; Barney Graham; Paul W Spearman; Mark Mulligan; Paul Goepfert Journal: J Acquir Immune Defic Syndr Date: 2002-03-01 Impact factor: 3.731
Authors: Daniel C Johnson; Elizabeth J McFarland; Petronella Muresan; Terence Fenton; James McNamara; Jennifer S Read; Elizabeth Hawkins; Pamela L Bouquin; Scharla G Estep; Georgia D Tomaras; Carol A Vincent; Mobeen Rathore; Ann J Melvin; Sanjay Gurunathan; John Lambert Journal: J Infect Dis Date: 2005-11-09 Impact factor: 5.226
Authors: H Cao; P Kaleebu; D Hom; J Flores; D Agrawal; N Jones; J Serwanga; M Okello; C Walker; H Sheppard; R El-Habib; M Klein; E Mbidde; P Mugyenyi; B Walker; J Ellner; R Mugerwa Journal: J Infect Dis Date: 2003-03-06 Impact factor: 5.226
Authors: Charles S Chasela; Michael G Hudgens; Denise J Jamieson; Dumbani Kayira; Mina C Hosseinipour; Athena P Kourtis; Francis Martinson; Gerald Tegha; Rodney J Knight; Yusuf I Ahmed; Deborah D Kamwendo; Irving F Hoffman; Sascha R Ellington; Zebrone Kacheche; Alice Soko; Jeffrey B Wiener; Susan A Fiscus; Peter Kazembe; Innocent A Mofolo; Maggie Chigwenembe; Dorothy S Sichali; Charles M van der Horst Journal: N Engl J Med Date: 2010-06-17 Impact factor: 91.245
Authors: Athena P Kourtis; Denise J Jamieson; Isabelle de Vincenzi; Allan Taylor; Michael C Thigpen; Halima Dao; Timothy Farley; Mary Glenn Fowler Journal: Am J Obstet Gynecol Date: 2007-09 Impact factor: 8.661
Authors: Anna Coutsoudis; Francois Dabis; Wafaie Fawzi; Philippe Gaillard; Geert Haverkamp; D Robert Harris; J Brooks Jackson; Valerie Leroy; Nicolas Meda; Philippe Msellati; Marie-Louise Newell; Ruth Nsuati; Jennifer S Read; Stefan Wiktor Journal: J Infect Dis Date: 2004-05-26 Impact factor: 5.226
Authors: Alemnesh H Mirkuzie; Sven Gudmund Hinderaker; Mitike Molla Sisay; Karen Marie Moland; Odd Mørkve Journal: J Int AIDS Soc Date: 2011-10-21 Impact factor: 5.396
Authors: Hannah L Itell; Erin P McGuire; Petronella Muresan; Coleen K Cunningham; Elizabeth J McFarland; William Borkowsky; Sallie R Permar; Genevieve G Fouda Journal: Vaccine Date: 2018-08-04 Impact factor: 3.641