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Safety and Immunological Response of a Boosting Dose of MVA-B in Healthy Volunteers After 4 Years of Receiving MVA-B

NCT01923610 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2017-03-21

No results posted yet for this study

Summary

24 healthy male and female volunteers who are at low risk of HIV infection and entered into the RISVAC02 study and were randomly allocated to receive 3 intramuscular injections of MVA-B at weeks 0, 4 and 16 will receive a boosting dose 4 years thereafter.

Participants will attend one of two clinical centres on at least 5 occasions over 16 weeks. These visits will comprise:

* Screening
* Trial entry and boosting immunisation
* Early follow-up after immunisation
* Follow-up x 2 including the final visit Participants will have blood and urine collected, and receive 1 immunisation. They will be counselled prior to and following a HIV test, and given health education on prevention of sexually transmitted infections including HIV. T

The two centres which participate are:

* Hospital Clinic, Barcelona and
* Hospital Gregorio Marañón, Madrid The primary objective is to explore the safety and immunogenicity of MVA-B.

Conditions

  • HIV Infections

Interventions

BIOLOGICAL

Experimental

Biological/Vaccine: MVA-B Modified Pox virus, strain MVA clade -B (expressing HIV-1 Bx08gp120 and IIIB gagpolnef) -\~ 1 x 10e8 pfu/ml 3 immunisations at week 0, 4 and 16

Sponsors & Collaborators

  • Hospital Clinic of Barcelona

    lead OTHER

Principal Investigators

  • Felipe Garcia, MD · Hospital Clínic i Provincial de Barcelona

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2014-09-30
Completion
2014-09-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01923610 on ClinicalTrials.gov