Long-term follow-up of study participants from prophylactic HIV vaccine clinical trials in Africa

Human Vaccines and Immunotherapeutics

Volumn 10, Issue 3, 2014, Pages 714-723

  Schmidt, Claudia ^a   Jaoko, Walter ^b   Omosa Manyonyi, Gloria ^b   Kaleebu, Pontiano ^c   Mpendo, Juliet ^c   Nanvubya, Annet ^c   Karita, Etienne ^d   Bayingana, Roger ^d   Bekker, Linda Gail ^e   Chomba, Elwyn ^f   Kilembe, William ^f   Nchabeleng, Maphoshane ^g   Nyombayire, Julien ^d   Stevens, Gwynn ^h   Chetty, Paramesh ^h   Lehrman, Jennifer ^a   Cox, Josephine ⁱ   Allen, Susan ^f   Dally, Len ^j   Smith, Carol ^j   Fast, Patricia E ^a   more..

^a INTERNATIONAL AIDS VACCINE INITIATIVE   (United States)

^b UNIVERSITY OF NAIROBI   (Kenya)

^c UVRI IAVI HIV Vaccine Program   (Uganda)

^d Projet San Francisco (PSF)   (Rwanda)

^e Institute of Infectious Disease and Molecular Medicine   (South Africa)

^f EMORY UNIVERSITY   (United States)

^g SEFAKO MAKGATHO HEALTH SCIENCES UNIVERSITY   (South Africa)

^h IAVI Clinical (Immunology) Laboratory   (South Africa)

ⁱ IMPERIAL COLLEGE LONDON   (United Kingdom)

^j EMMES CORPORATION   (United States)

more..

Author keywords

Africa; Healthy adult volunteers; HIV vaccine trials; Long term follow up; Safety

Indexed keywords

HUMAN IMMUNODEFICIENCY VIRUS ANTIBODY; HUMAN IMMUNODEFICIENCY VIRUS VACCINE; PLACEBO;

ADULT; AFRICA; ANTIBODY PRODUCTION; ARTICLE; CELLULAR IMMUNITY; CONGENITAL MALFORMATION; CONTROLLED STUDY; DRUG MEGADOSE; DRUG SAFETY; FEMALE; FOLLOW UP; HIV TEST; HUMAN; HUMAN CELL; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; IMMUNE RESPONSE; LOW DRUG DOSE; MAJOR CLINICAL STUDY; MALE; OBSERVATIONAL STUDY; PAIN; PARESTHESIA; PREGNANCY; PRURITUS; QUESTIONNAIRE; SCAR; VACCINATION; ADOLESCENT; CLINICAL TRIAL (TOPIC); HEALTH STATUS; HIV INFECTIONS; IMMUNOLOGY; MIDDLE AGED; MONONUCLEAR CELL; YOUNG ADULT;

ADOLESCENT; ADULT; AFRICA; AIDS VACCINES; CLINICAL TRIALS AS TOPIC; FEMALE; FOLLOW-UP STUDIES; HEALTH STATUS; HIV INFECTIONS; HUMANS; LEUKOCYTES, MONONUCLEAR; MALE; MIDDLE AGED; PREGNANCY; SURVEYS AND QUESTIONNAIRES; YOUNG ADULT;

EID: 84898457769     PISSN: 21645515     EISSN: 2164554X     Source Type: Journal    
DOI: 10.4161/hv.27559     Document Type: Article

References (17)

1. Peters BS, Jaoko W, Vardas E, Panayotakopoulos G, Fast P, Schmidt C, Gilmour J, Bogoshi M, Omosa-Manyonyi G, Dally L, et al. Studies of a prophylactic HIV-1 vaccine candidate based on modified vaccinia virus Ankara (MVA) with and without DNA priming: effects of dosage and route on safety and immunogenicity. Vaccine 2007; 25:2120-7; PMID:17250931; http://dx.doi.org/10. 1016/j.vaccine.2006.11.016
2. Jaoko W, Nakwagala FN, Anzala O, Manyonyi GO, Birungi J, Nanvubya A, Bashir F, Bhatt K, Ogutu H, Wakasiaka S, et al. Safety and immunogenicity of recombinant low-dosage HIV-1 A vaccine candidates vectored by plasmid pTHr DNA or modified vaccinia virus Ankara (MVA) in humans in East Africa. Vaccine 2008; 26:2788-95; PMID:18440674; http://dx.doi.org/10.1016/j.vaccine.2008.02.071
3. Vardas E, Kaleebu P, Bekker LG, Hoosen A, Chomba E, Johnson PR, Anklesaria P, Birungi J, Barin B, Boaz M, et al. A phase 2 study to evaluate the safety and immunogenicity of a recombinant HIV type 1 vaccine based on adeno-associated virus. AIDS Res Hum Retroviruses 2010; 26:933-42; PMID:20666584; http://dx.doi.org/10.1089/aid.2009.0242
4. Jaoko W, Karita E, Kayitenkore K, Omosa-Manyonyi G, Allen S, Than S, Adams EM, Graham BS, Koup RA, Bailer RT, et al. Safety and immunogenicity study of Multiclade HIV-1 adenoviral vector vaccine alone or as boost following a multiclade HIV-1 DNA vaccine in Africa. PLoS One 2010; 5:e12873; PMID:20877623; http://dx.doi.org/10.1371/journal.pone.0012873
5. Gilbert PB, Chiu Y-L, Allen M, Lawrence DN, Chapdu C, Israel H, Holman D, Keefer MC, Wolff M, Frey SE; NIAID HIV Vaccine Trials Network. Long-term safety analysis of preventive HIV-1 vaccines evaluated in AIDS vaccine evaluation group NIAID-sponsored Phase I and II clinical trials. Vaccine 2003; 21:2933-47; PMID:12798637; http://dx.doi.org/10.1016/S0264-410X(03)00158-0
6. Schmidt C, Smith C, Barin B, Bakhtyari A, Bart PA, Bekker LG, Chomba E, Clumeck N, Ho D, Hoosen A, et al. Background morbidity in HIV vaccine trial participants from various geographic regions as assessed by unsolicited adverse events. Hum Vaccin Immunother 2012; 8:630-8; http://dx.doi.org/10.4161/hv.19454; PMID:22634443
7. Centers for Disease Control and Prevention (CDC). Cardiac adverse events following smallpox vaccination - United States, 2003. MMWR Morb Mortal Wkly Rep 2003; 52:248-50; PMID:12680519
8. Centers for Disease Control and Prevention (CDC). Update: cardiac-related events during the civilian smallpox vaccination program - United States, 2003. MMWR Morb Mortal Wkly Rep 2003; 52:492-6; PMID:12809110
9. Vasan S, Schlesinger SJ, Chen Z, Hurley A, Lombardo A, Than S, Adesanya P, Bunce C, Boaz M, Boyle R, et al. Phase 1 safety and immunogenicity evaluation of ADMVA, a multigenic, modified vaccinia Ankara-HIV-1 B'/C candidate vaccine. PLoS One 2010; 5:e8816; PMID:20111599; http://dx.doi.org/10.1371/journal.pone. 0008816
10. Ramanathan VD, Kumar M, Mahalingam J, Sathyamoorthy P, Narayanan PR, Solomon S, Panicali D, Chakrabarty S, Cox J, Sayeed E, et al. A Phase 1 study to evaluate the safety and immunogenicity of a recombinant HIV type 1 subtype C-modified vaccinia Ankara virus vaccine candidate in Indian volunteers. AIDS Res Hum Retroviruses 2009; 25:1107-16; PMID:19943789; http://dx.doi.org/10.1089/ aid.2009.0096
11. Elizaga ML, Vasan S, Marovich MA, Sato AH, Lawrence DN, Chaitman BR, Frey SE, Keefer MC; MVA Cardiac Safety Working Group. Prospective surveillance for cardiac adverse events in healthy adults receiving modified vaccinia Ankara vaccines: a systematic review. PLoS One 2013; 8:e54407; PMID:23349878; http://dx.doi.org/10.1371/journal.pone.0054407
12. Poster # 164668: Karita E, Kayitesi K, Bayingama R, Sebahungu F, Bizimana J, Grabowski K, et al. Use of HIV rapid test for assessment of persistence of vaccine-induced antibodies among HIV vaccine recipients. AIDS Vaccine 2009, Paris, October 2009.
13. Van Braeckel E, Koutsoukos M, Bourguignon P, Clement F, McNally L, Leroux-Roels G. Vaccineinduced HIV seropositivity: a problem on the rise. J Clin Virol 2011; 50:334-7; http://dx.doi.org/10.1016/j.jcv.2011.01.003; PMID:21300566
14. Cooper CJ, Metch B, Dragavon J, Coombs RW, Baden LR; NIAID HIV Vaccine Trials Network (HVTN) Vaccine-Induced Seropositivity (VISP) Task Force. Vaccine-induced HIV seropositivity/reactivity in noninfected HIV vaccine recipients. JAMA 2010; 304:275-83; http://dx.doi.org/10.1001/jama.2010.926; PMID:20639561
15. DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events. www.rsc-tech.com
16. Boaz MJ, Hayes P, Tarragona T, Seamons L, Cooper A, Birungi J, Kitandwe P, Semaganda A, Kaleebu P, Stevens G, et al. Concordant proficiency in measurement of T-cell immunity in human immunodeficiency virus vaccine clinical trials by peripheral blood mononuclear cell and enzymelinked immunospot assays in laboratories from three continents. Clin Vaccine Immunol 2009; 16:147-55; PMID:19091991; http://dx.doi.org/10.1128/CVI.00326-08
17. Keefer MC, Gilmour J, Hayes P, Gill D, Kopycinski J, Cheeseman H, Cashin-Cox M, Naarding M, Clark L, Fernandez N, et al. A phase I double blind, placebocontrolled, randomized study of a multigenic HIV-1 adenovirus subtype 35 vector vaccine in healthy uninfected adults. PLoS One 2012; 7:e41936; PMID:22870265; http://dx.doi.org/10.1371/journal.pone.0041936