Abstract
The safety and immunogenicity of a new candidate tuberculosis (TB) vaccine, FP85A was evaluated alone and in heterologous prime-boost regimes with another candidate TB vaccine, MVA85A. This was an open label, non-controlled, non-randomized Phase I clinical trial. Healthy previously BCG-vaccinated adult subjects were enrolled sequentially into three groups and vaccinated with FP85A alone, or both FP85A and MVA85A, with a four week interval between vaccinations. Passive and active data on adverse events were collected. Immunogenicity was evaluated by Enzyme Linked Immunospot (ELISpot), flow cytometry and Enzyme Linked Immunosorbent assay (ELISA ). Most adverse events were mild and there were no vaccine-related serious adverse events. FP85A vaccination did not enhance antigen 85A-specific cellular immunity. When MVA85A vaccination was preceded by FP85A vaccination, cellular immune responses were lower compared with when MVA85A vaccination was the first immunisation. MVA85A vaccination, but not FP85A vaccination, induced anti-MVA IgG antibodies. Both MVA85A and FP85A vaccinations induced anti-FP9 IgG antibodies. In conclusion, FP85A vaccination was well tolerated but did not induce antigen-specific cellular immune responses. We hypothesize that FP85A induced anti-FP9 IgG antibodies with cross-reactivity for MVA85A, which may have mediated inhibition of the immune response to subsequent MVA85A. ClinicalTrials.gov identification number: NCT00653770.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 50-62 |
| Number of pages | 13 |
| Journal | Human Vaccines and Immunotherapeutics |
| Volume | 9 |
| Issue number | 1 |
| DOIs | |
| State | Published - Jan 1 2013 |
| Externally published | Yes |
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Keywords
- Heterologous prime-boost regimes
- Phase I clinical trial
- Poxvirus-vectored subunit vaccines
- Tuberculosis vaccines
ASJC Scopus subject areas
- Immunology and Allergy
- Immunology
- Pharmacology
Cite this
Safety and immunogenicity of an FP9-vectored candidate tuberculosis vaccine (FP85A), alone and with candidate vaccine MVA85A in BCG-vaccinated healthy adults : A phase i clinical trial. / Rowland, Rosalind; Pathan, Ansar A.; Satti, Iman; Poulton, Ian D.; Matsumiya, Magali M.L.; Whittaker, Megan; Minassian, Angela M.; O'Hara, Geraldine A.; Hamill, Matthew; Scott, Janet T.; Harris, Stephanie A.; Poyntz, Hazel C.; Bateman, Cynthia; Meyer, Joel; Williams, Nicola; Gilbert, Sarah C.; Lawrie, Alison M.; Hill, Adrian V.S.; McShane, Helen.
In: Human Vaccines and Immunotherapeutics, Vol. 9, No. 1, 01.01.2013, p. 50-62.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Safety and immunogenicity of an FP9-vectored candidate tuberculosis vaccine (FP85A), alone and with candidate vaccine MVA85A in BCG-vaccinated healthy adults
T2 - A phase i clinical trial
AU - Rowland, Rosalind
AU - Pathan, Ansar A.
AU - Satti, Iman
AU - Poulton, Ian D.
AU - Matsumiya, Magali M.L.
AU - Whittaker, Megan
AU - Minassian, Angela M.
AU - O'Hara, Geraldine A.
AU - Hamill, Matthew
AU - Scott, Janet T.
AU - Harris, Stephanie A.
AU - Poyntz, Hazel C.
AU - Bateman, Cynthia
AU - Meyer, Joel
AU - Williams, Nicola
AU - Gilbert, Sarah C.
AU - Lawrie, Alison M.
AU - Hill, Adrian V.S.
AU - McShane, Helen
PY - 2013/1/1
Y1 - 2013/1/1
N2 - The safety and immunogenicity of a new candidate tuberculosis (TB) vaccine, FP85A was evaluated alone and in heterologous prime-boost regimes with another candidate TB vaccine, MVA85A. This was an open label, non-controlled, non-randomized Phase I clinical trial. Healthy previously BCG-vaccinated adult subjects were enrolled sequentially into three groups and vaccinated with FP85A alone, or both FP85A and MVA85A, with a four week interval between vaccinations. Passive and active data on adverse events were collected. Immunogenicity was evaluated by Enzyme Linked Immunospot (ELISpot), flow cytometry and Enzyme Linked Immunosorbent assay (ELISA ). Most adverse events were mild and there were no vaccine-related serious adverse events. FP85A vaccination did not enhance antigen 85A-specific cellular immunity. When MVA85A vaccination was preceded by FP85A vaccination, cellular immune responses were lower compared with when MVA85A vaccination was the first immunisation. MVA85A vaccination, but not FP85A vaccination, induced anti-MVA IgG antibodies. Both MVA85A and FP85A vaccinations induced anti-FP9 IgG antibodies. In conclusion, FP85A vaccination was well tolerated but did not induce antigen-specific cellular immune responses. We hypothesize that FP85A induced anti-FP9 IgG antibodies with cross-reactivity for MVA85A, which may have mediated inhibition of the immune response to subsequent MVA85A. ClinicalTrials.gov identification number: NCT00653770.
AB - The safety and immunogenicity of a new candidate tuberculosis (TB) vaccine, FP85A was evaluated alone and in heterologous prime-boost regimes with another candidate TB vaccine, MVA85A. This was an open label, non-controlled, non-randomized Phase I clinical trial. Healthy previously BCG-vaccinated adult subjects were enrolled sequentially into three groups and vaccinated with FP85A alone, or both FP85A and MVA85A, with a four week interval between vaccinations. Passive and active data on adverse events were collected. Immunogenicity was evaluated by Enzyme Linked Immunospot (ELISpot), flow cytometry and Enzyme Linked Immunosorbent assay (ELISA ). Most adverse events were mild and there were no vaccine-related serious adverse events. FP85A vaccination did not enhance antigen 85A-specific cellular immunity. When MVA85A vaccination was preceded by FP85A vaccination, cellular immune responses were lower compared with when MVA85A vaccination was the first immunisation. MVA85A vaccination, but not FP85A vaccination, induced anti-MVA IgG antibodies. Both MVA85A and FP85A vaccinations induced anti-FP9 IgG antibodies. In conclusion, FP85A vaccination was well tolerated but did not induce antigen-specific cellular immune responses. We hypothesize that FP85A induced anti-FP9 IgG antibodies with cross-reactivity for MVA85A, which may have mediated inhibition of the immune response to subsequent MVA85A. ClinicalTrials.gov identification number: NCT00653770.
KW - Heterologous prime-boost regimes
KW - Phase I clinical trial
KW - Poxvirus-vectored subunit vaccines
KW - Tuberculosis vaccines
UR - http://www.scopus.com/inward/record.url?scp=84874748140&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84874748140&partnerID=8YFLogxK
U2 - 10.4161/hv.22464
DO - 10.4161/hv.22464
M3 - Article
C2 - 23143773
AN - SCOPUS:84874748140
VL - 9
SP - 50
EP - 62
JO - Human Vaccines and Immunotherapeutics
JF - Human Vaccines and Immunotherapeutics
SN - 2164-5515
IS - 1
ER -