Condition category
Infections and Infestations
Date applied
07/09/2005
Date assigned
21/09/2005
Last edited
18/01/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.ctu.mrc.ac.uk/studies/eurovac1.asp

Contact information

Type

Scientific

Primary contact

Dr Sheena McCormack

ORCID ID

Contact details

MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

EV01

Study information

Scientific title

Acronym

EuroVac01

Study hypothesis

To explore the safety and immunogenicity of two injections of NYVAC HIV-C in healthy male and female volunteers at low risk of HIV infection.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Human immunodeficiency virus (HIV)

Intervention

NYVAC-HIV C (vP2010) or placebo.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

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 outcome measures

1. All grade 1 and 2 adverse events within 28 days of a vaccination
2. Antibody responses
3. Cellular responses

Overall trial start date

04/08/2003

Overall trial end date

07/10/2004

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

24

Participant 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

Recruitment start date

04/08/2003

Recruitment end date

07/10/2004

Locations

Countries of recruitment

Switzerland, United Kingdom

Trial participating centre

MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom

Sponsor information

Organisation

Imperial College London (UK)

Sponsor details

Research Services
Faculty Building
Exhibition Road
London
SW7 2AZ
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

European Commission (5th Framework programme) (Belgium)

Alternative name(s)

EC

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

Belgium

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18502002

Publication citations

  1. Results

    Bart PA, Goodall R, Barber T, Harari A, Guimaraes-Walker A, Khonkarly M, Sheppard NC, Bangala Y, Frachette MJ, Wagner R, Liljeström P, Kraehenbuhl JP, Girard M, Goudsmit J, Esteban M, Heeney J, Sattentau Q, McCormack S, Babiker A, Pantaleo G, Weber J, , EV01: a phase I trial in healthy HIV negative volunteers to evaluate a clade C HIV vaccine, NYVAC-C undertaken by the EuroVacc Consortium., Vaccine, 2008, 26, 25, 3153-3161, doi: 10.1016/j.vaccine.2008.03.083.

Additional files

Editorial Notes