A phase I trial to assess the safety of 4 ml DNA C (intramuscular [IM]), and the safety and immunogenicity of DNA C followed by NYVAC C (IM) in an open, randomised comparison to NYVAC C alone in healthy volunteers at low risk of human immunodeficiency virus (HIV) infection
| ISRCTN | ISRCTN26673492 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN26673492 |
| Secondary identifying numbers | EV02 |
- Submission date
- 06/09/2005
- Registration date
- 21/09/2005
- Last edited
- 18/01/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Sheena McCormack
Scientific
Scientific
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | |
| Study acronym | EuroVac 02 |
| Study objectives | The primary objectives are to explore the safety of the DNA C construct and the prime-boost regimen, and to compare the immunogenicity of the prime boost regimen to the single agent NYVAC C in healthy volunteers at low risk of HIV infection. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Human immunodeficiency virus (HIV) |
| Intervention | DNA HIV-C & NYVAC HIV-C (vP2010)vaccines versus NYVAC HIV-C alone. |
| Intervention type | Other |
| Primary outcome measure | 1. Safety: local & general adverse events within 7 and 28 days 2. Immunogenicity: cellular responses assessed using the ELISPOT technique |
| Secondary outcome measures | 1. All grade 1 and 2 adverse events within 28 days of a vaccination 2. Antibody responses 3. Cellular responses |
| Overall study start date | 21/02/2005 |
| Completion date | 24/07/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 40 |
| Key inclusion criteria | 1. Age between 18 and 55 years on the day of screening 2. Available for follow-up for the duration of the study (54 weeks from screening) 3. Able to give written informed consent 4. At low risk of HIV and willing to remain so for the duration of the study 5. Willing to undergo a HIV test 6. Willing to undergo a genital infection screen 7. 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 8. 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 |
| Key exclusion criteria | 1. Pregnant or lactating 2. Clinically relevant abnormality on history or examination including history of grand-mal epilepsy, severe eczema, allergy to eggs, 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. Positive for DNA/ANA antibodies at titre considered clinically relevant by immunology laboratory 10. Grade 1 routine laboratory parameters 11. Unlikely to comply with protocol |
| Date of first enrolment | 21/02/2005 |
| Date of final enrolment | 24/07/2006 |
Locations
Countries of recruitment
- England
- Switzerland
- United Kingdom
Study participating centre
MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom
NW1 2DA
United Kingdom
Sponsor information
EuroVacc Foundation (Switzerland)
Research organisation
Research organisation
6, Rue de la Grotte
Lausanne
1003
Switzerland
| Website | http://www.eurovacc.org |
|---|---|
"ROR" |
https://ror.org/04f2nz275 |
Funders
Funder type
Government
European Commission (5th Framework Programme) (Belgium)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- European Union, Comisión Europea, Europäische Kommission, EU-Kommissionen, Euroopa Komisjoni, Ευρωπαϊκής Επιτροπής, Европейската комисия, Evropské komise, Commission européenne, Choimisiúin Eorpaigh, Europskoj komisiji, Commissione europea, La Commissione europea, Eiropas Komisiju, Europos Komisijos, Európai Bizottságról, Europese Commissie, Komisja Europejska, Comissão Europeia, Comisia Europeană, Európskej komisii, Evropski komisiji, Euroopan komission, Europeiska kommissionen, EC, EU
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 13/06/2008 | Yes | No |
