Safety and Immunogenicity of ChAd63 and MVA ME-TRAP in West African Children and Infants

Molecular Therapy

Volumn 24, Issue 8, 2016, Pages 1470-1477

  Afolabi, Muhammed O ^a   Tiono, Alfred B ^b   Adetifa, Uche J ^a   Yaro, Jean Baptiste ^b   Drammeh, Abdoulie ^a   Nébié, Issa ^b   Bliss, Carly ^c   Hodgson, Susanne H ^d   Anagnostou, Nicholas A ^d   Sanou, Guillaume S ^b   Jagne, Ya Jankey ^a   Ouedraogo, Oumarou ^b   Tamara, Casimir ^b   Ouedraogo, Nicolas ^b   Ouedraogo, Mirielle ^b   Njie Jobe, Jainaba ^a   Diarra, Amidou ^b   Duncan, Christopher J A ^d   Cortese, Riccardo ^e   Nicosia, Alfredo ^f,g,h   Roberts, Rachel ^d   Viebig, Nicola K ⁱ   Leroy, Odile ⁱ   Lawrie, Alison M ^d   Flanagan, Katie L ^a,j   Kampman, Beate ^a   Bejon, Philip ^k   Imoukhuede, Egeruan B ^d   Ewer, Katie J ^c   Hill, Adrian V S ^c,d   Bojang, Kalifa ^a   Sirima, Sodiomon B ^b   more..

^a MEDICAL RESEARCH COUNCIL LABORATORIES   (Gambia)

^b Burkina Faso   (Burkina Faso)

^c UNIVERSITY OF OXFORD   (United Kingdom)

^d CHURCHILL HOSPITAL   (United Kingdom)

^e Keires AG   (Switzerland)

^f ReiThera ^*  (Italy)

^g CEINGE BIOTECNOLOGIE AVANZATE   (Italy)

^h UNIVERSITY OF NAPLES FEDERICO II   (Italy)

ⁱ UNIVERSITY HOSPITAL HEIDELBERG   (Germany)

^j MONASH UNIVERSITY   (Australia)

^k KENYA MEDICAL RESEARCH INSTITUTE   (Kenya)

more..

Author keywords

[No Author keywords available]

Indexed keywords

CHIMPANZEE ADENOVIRUS 63 MULTIPLE EPITOPE THROMBOSPONDIN ADHESION PROTEIN; MALARIA VACCINE; MODIFIED VACCINIA VIRUS ANKARA MULTIPLE EPITOPE THROMBOSPONDIN ADHESION PROTEIN; RABIES VACCINE; UNCLASSIFIED DRUG; EPITOPE; PROTOZOON ANTIBODY;

ARTICLE; BURKINA FASO; BURKINABE; CHILD; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOSE RESPONSE; DRUG DOSE ESCALATION; DRUG DOSE INCREASE; DRUG MEGADOSE; DRUG SAFETY; DRUG TOLERABILITY; FEVER; GAMBIAN; GROUPS BY AGE; HUMAN; IMMUNOGENICITY; INFANT; INFECTION PREVENTION; INJECTION SITE PAIN; LOW DRUG DOSE; MALARIA; PHASE 1 CLINICAL TRIAL; RABIES; RANDOMIZED CONTROLLED TRIAL; SINGLE BLIND PROCEDURE; T LYMPHOCYTE; VACCINATION; ADVERSE EFFECTS; AFRICA; ANIMAL; BLOOD; CLINICAL TRIAL; ENZYME LINKED IMMUNOSPOT ASSAY; GAMBIA; GENE VECTOR; IMMUNOLOGY; NEWBORN; OUTCOME ASSESSMENT; PRESCHOOL CHILD; SECONDARY IMMUNIZATION; SIMIAN VIRUS; VACCINIA VIRUS;

ADENOVIRUSES, SIMIAN; AFRICA, WESTERN; ANIMALS; ANTIBODIES, PROTOZOAN; CHILD; CHILD, PRESCHOOL; ENZYME-LINKED IMMUNOSPOT ASSAY; EPITOPES; GAMBIA; GENETIC VECTORS; HUMANS; IMMUNIZATION, SECONDARY; INFANT; INFANT, NEWBORN; MALARIA; MALARIA VACCINES; OUTCOME ASSESSMENT (HEALTH CARE); VACCINIA VIRUS;

EID: 84976353320     PISSN: 15250016     EISSN: 15250024     Source Type: Journal    
DOI: 10.1038/mt.2016.83     Document Type: Article

References (24)

1. WHO (2011). Malaria deaths are down but progress remains fragile. 13 December 2011. World Health Organization, Geneva.
2. Murray, CJ, Rosenfeld, LC, Lim, SS, Andrews, KG, Foreman, KJ, Haring, D et al. (2012). Global malaria mortality between 1980 and 2010: a systematic analysis. Lancet 379: 413-431.
3. Crompton, PD, Pierce, SK and Miller, LH (2010). Advances and challenges in malaria vaccine development. J Clin Invest 120: 4168-4178.
4. Agnandji, ST, Lell, B, Soulanoudjingar, SS, Fernandes, JF, Abossolo, BP, Conzelmann, C et al.; RTS,S Clinical Trials Partnership. (2011). First results of phase 3 trial of RTS,S/AS01 malaria vaccine in African children. N Engl J Med 365: 1863-1875.
5. RTSS Clinical trials partnership (2015). Efficacy and safety of RTS,S/AS01 malaria vaccine with or without a booster dose in infants and children in Africa: final results of a phase 3, individually randomised, controlled trial. Lancet 386: 31-45.
6. Radosevi, K, Rodriguez, A, Lemckert, A and Goudsmit, J (2009). Heterologous prime-boost vaccinations for poverty-related diseases: advantages and future prospects. Expert Rev Vaccines 8: 577-592.
7. Green, CA, Scarselli, E, Sande, CJ, Thompson, AJ, de Lara, CM, Taylor, KS et al. (2015). Chimpanzee adenovirus-and MVA-vectored respiratory syncytial virus vaccine is safe and immunogenic in adults. Sci Transl Med 7: 300-126.
8. Sheehy, SH, Duncan, CJ, Elias, SC, Biswas, S, Collins, KA, O'Hara, GA et al. (2012). Phase Ia clinical evaluation of the safety and immunogenicity of the Plasmodium falciparum blood-stage antigen AMA1 in ChAd63 and MVA vaccine vectors. PLoS One 7: e31208.
9. Ewer, KJ, O'Hara, GA, Duncan, CJ, Collins, KA, Sheehy, SH, Reyes-Sandoval, A et al. (2013). Protective CD8+ T-cell immunity to human malaria induced by chimpanzee adenovirus-MVA immunisation. Nat Commun 4: 2836.
10. Borthwick, N, Ahmed, T, Ondondo, B, Hayes, P, Rose, A, Ebrahimsa, U et al. (2014). Vaccine-elicited human T cells recognizing conserved protein regions inhibit HIV-1. Mol Ther 22: 464-475.
11. Borthwick, NJ, Rosario, M, Schiffner, T, Bowles, E, Ahmed, T, Liljeström, P et al. (2015). Humoral responses to HIVconsv induced by heterologous vaccine modalities in rhesus macaques. Immun Inflamm Dis 3: 82-93.
12. Antrobus, RD, Lillie, PJ, Berthoud, TK, Spencer, AJ, McLaren, JE, Ladell, K et al. (2012). A T cell-inducing influenza vaccine for the elderly: safety and immunogenicity of MVANP+ M1 in adults aged over 50 years. PLoS One 7: e48322.
13. Swadling, L, Capone, S, Antrobus, RD, Brown, A, Richardson, R, Newell, EW et al. (2014). A human vaccine strategy based on chimpanzee adenoviral and MVA vectors that primes, boosts, and sustains functional HCV-specific T cell memory. Sci Transl Med 6: 261ra153.
14. Kagina, BM, Tameris, MD, Geldenhuys, H, Hatherill, M, Abel, B, Hussey, GD et al.; 018-402 Clinical Lab study team. (2014). The novel tuberculosis vaccine, AERAS-402, is safe in healthy infants previously vaccinated with BCG, and induces dose-dependent CD4 and CD8T cell responses. Vaccine 32: 5908-5917.
15. Tameris, M, Geldenhuys, H, Luabeya, AK, Smit, E, Hughes, JE, Vermaak, S et al. (2014). The candidate TB vaccine, MVA85A, induces highly durable Th1 responses. PLoS One 9: e87340.
16. Tameris, MD, Hatherill, M, Landry, BS, Scriba, TJ, Snowden, MA, Lockhart, S et al.; MVA85A 020 Trial Study Team. (2013). Safety and efficacy of MVA85A, a new tuberculosis vaccine, in infants previously vaccinated with BCG: a randomised, placebo-controlled phase 2b trial. Lancet 381: 1021-1028.
17. Ceesay, SJ, Casals-Pascual, C, Erskine, J, Anya, SE, Duah, NO, Fulford, AJ et al. (2008). Changes in malaria indices between 1999 and 2007 in The Gambia: a retrospective analysis. Lancet 372: 1545-1554.
18. Tiono, AB, Kangoye, DT, Rehman, AM, Kargougou, DG, Kaboré, Y, Diarra, A et al. (2014). Malaria incidence in children in South-West Burkina Faso: comparison of active and passive case detection methods. PLoS One 9: e86936.
19. Bejon, P, Mwacharo, J, Kai, O, Mwangi, T, Milligan, P, Todryk, S et al. (2006). A phase 2b randomised trial of the candidate malaria vaccines FP9 ME-TRAP and MVA ME-TRAP among children in Kenya. PLoS Clin Trials 1: e29.
20. Bejon, P, Ogada, E, Mwangi, T, Milligan, P, Lang, T, Fegan, G et al. (2007). Extended follow-up following a phase 2b randomized trial of the candidate malaria vaccines FP9 ME-TRAP and MVA ME-TRAP among children in Kenya. PLoS One 2: e707.
21. Ceesay, SJ, Casals-Pascual, C, Nwakanma, DC, Walther, M, Gomez-Escobar, N, Fulford, AJ et al. (2010). Continued decline of malaria in The Gambia with implications for elimination. PLoS One 5: e12242.
22. Mwesigwa, J, Okebe, J, Affara, M, Di Tanna, GL, Nwakanma, D, Janha, O et al. (2015). On-going malaria transmission in The Gambia despite high coverage of control interventions: a nationwide cross-sectional survey. Malar J 14: 314.
23. Ogwang, C, Afolabi, M, Kimani, D, Jagne, YJ, Sheehy, SH, Bliss, CM et al. (2013). Safety and immunogenicity of heterologous prime-boost immunisation with Plasmodium falciparum malaria candidate vaccines, ChAd63 ME-TRAP and MVA ME-TRAP, in healthy Gambian and Kenyan adults. PLoS One 8: e57726.
24. Kimani, D, Jagne, YJ, Cox, M, Kimani, E, Bliss, CM, Gitau, E et al. (2014). Translating the immunogenicity of prime-boost immunization with ChAd63 and MVA ME-TRAP from malaria naive to malaria-endemic populations. Mol Ther 22: 1992-2003.