A first-in-human study of a novel HPV vaccine in healthy subjects
Research type
Research Study
Full title
A First-in-Human, Phase 1, Randomized, Placebo-Controlled, Double-Blind Study to Assess the Safety and Tolerability, and to Explore Immunological Effects of Intramuscularly Administered AAVLP-HPV Vaccine in Healthy Adult Male and Female Subjects.
IRAS ID
253112
Contact name
David Bell
Contact email
Sponsor organisation
2A Pharma AB
Eudract number
2018-003045-42
Duration of Study in the UK
1 years, 0 months, 18 days
Research summary
Summary of Research
This clinical trial will be a FIH study of AAVLP-HPV vaccine for injection. When developing new vaccines for clinical indications, it is necessary to collect data on the safety, tolerability, and immunogenicity in order to support further development of the compound as a useful clinical candidate and allow recommendations of dose levels and dose intervals in Phase 2 and subsequent studies.Summary of Results
: AAVLP-HPV vaccine administration appeared to be safe and well tolerated in the male and female subjects in this study. There were no deaths, Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), or subject discontinuations due to Adverse Events (Aes) in this study. A total of 2 subjects (1 following AAVLP-HPV vaccine administration and 1 following placebo) experienced the event of increased creatine kinase (CK), and there was one reported pregnancy at the follow-up visit approximately 6 months after the last AAVLP-HPV vaccine administration.The geometric mean fold rise (GMFR) of anti AAVLP-HPV (capsid peptide HPV types 16 and 31) antibody titers tended to increase in the initial period following each of the 3 intra-muscular injections of AAVLP-HPV vaccine on Days 1, 57, and 180, with the highest GMFR for both capsid peptide HPV (HPV 16 L2 and HPV 31 L2) types observed 2 weeks after the first boost injection on Day 57. The magnitude of each antibody response then decreased until the next vaccine injection, and from 2 weeks after the last boost injection (Day 180) decreased until Day 365.
Clear antibody responses were seen for HPV 16 L2, HPV 20 L2 and HPV 31 L2 in both the evaluation of relative treatment effect (10-fold increase) and the proportion of responders. Similar but less pronounced responses were seen for HPV 5 L2, HPV 15 L2, and HPV 76 L2 in both the evaluation of relative treatment effect (at least 5-fold increase) and the proportion of responders. A similar pattern was seen for HPV 38 L2 without reaching a significant level in any of the analyses. This could potentially be explained by a relative high baseline level for HPV 38.
In summary, the vaccine appeared safe and well tolerated, and elicited robust antibody response against some HPV types in some subjects
REC name
HSC REC A
REC reference
18/NI/0158
Date of REC Opinion
3 Oct 2018
REC opinion
Favourable Opinion