Human immunodeficiency virus (HIV) Infections and Infestations Human immunodeficiency virus (HIV)
Conditions
Interventions
NYVAC-HIV C (vP2010) or placebo.
Sponsors
Imperial College London (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female 2. Age between 18 and 55 years on the day of screening 3. Available for follow-up for the duration of the study (52 weeks from screening) 4. Able to give written informed consent 5. At low risk of HIV and willing to remain so for the duration of the study 6. Willing to undergo a HIV test 7. Willing to undergo a genital infection screen 8. If heterosexually active female, using an effective method of contraception with partner (combined oral contraceptive pill; injectable contraceptive; intra-uterine contraceptive device [IUCD]; consistent record with condoms if using these; physiological or anatomical sterility in self or partner) from 14 days prior to the first vaccination until 4 months after the last, and willing to undergo urine pregnancy tests prior to each vaccination 9. If heterosexually active male, using an effective method of contraception with their partner from the first day of vaccination until 4 months after the last vaccination
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating 2. Clinically relevant abnormality on history or examination including history of grand-mal epilepsy, severe eczema, immunodeficiency or use of immunosuppressives in preceding 3 months 3. Receipt of live attenuated vaccine within 60 days or other vaccine within 14 days of enrolment 4. Receipt of blood products or immunoglobin within 4 months of screening 5. Participation in another trial of a medicinal product, completed less than 30 days prior to enrolment 6. History of severe local or general reaction to vaccination 7. HIV 1/2 positive or indeterminate on screening 8. Positive for hepatitis B surface antigen, hepatitis C antibody or serology indicating active syphilis requiring treatment 9. Grade 1 routine laboratory parameters 10. Unlikely to comply with protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The safety and immunogenicity of NYVAC C, and the respective end-points are: 1. Safety: grade 3 or above local general adverse events 2. Immunogenicity: cellular responses assessed using the ELISPOT technique | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. All grade 1 and 2 adverse events within 28 days of a vaccination 2. Antibody responses 3. Cellular responses | — |
Countries
Switzerland, United Kingdom
Outcome results
None listed