Safety and Immunological Response of a Boosting Dose of MVA-B in Healthy Volunteers After 4 Years of Receiving MVA-B
Primary Purpose
HIV Infections
Status
Completed
Phase
Phase 1
Locations
Spain
Study Type
Interventional
Intervention
Experimental
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Low risk HIV infection, HIV Seronegativity, HIV Preventive Vaccine
Eligibility Criteria
Inclusion Criteria:
- male or female
- age between 18 and 55 years on the day of screening
- available for follow-up for the duration of the study (52 weeks from screening)
- able to give written informed consent
- at low risk of HIV and willing to remain so for the duration of the study low risk of HIV infection defined as: no history of injecting drug use in the previous ten years no gonorrhoea or syphilis in the last six months no high risk partner (e.g. injecting drug use, HIV positive partner) either currently or within the past six months no unprotected anal intercourse in the last six months no unprotected vaginal intercourse outside a relationship with a regular known/presumed HIV negative partner in the last six months
- willing to undergo a HIV test
- willing to undergo a genital infection screen
- if heterosexually active female, using an effective method of contraception with partner (combined oral contraceptive pill; injectable contraceptive; 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
- 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:
- positive for hepatitis B surface antigen, hepatitis C antibody, antibody responses to vaccinia or serology indicating active syphilis requiring treatment
- pregnant or lactating
- clinically relevant abnormality on history or examination including history of grand-mal epilepsy, severe eczema, immunodeficiency or use of immunosuppressives in preceding 3 months
- receipt of live attenuated vaccine within 60 days or other vaccine within 14 days of enrolment
- receipt of blood products or immunoglobin within 4 months of screening
- participation in another trial of a medicinal product, completed less than 30 days prior to enrolment
- history of severe local or general reaction to vaccination defined as local: extensive, indurated redness and swelling involving most of the front-lateral thigh or the major circumference of the arm, not resolving within 72 hours general: fever >= 39.5oC within 48 hours; anaphylaxis; bronchospasm; laryngeal
- HIV 1/2 positive or indeterminate on screening
- positive for hepatitis B surface antigen, hepatitis C antibody or serology indicating active syphilis requiring treatment
- grade 1 routine laboratory parameters
- unlikely to comply with protocol
Sites / Locations
- Hospital Clínic i Provincial de Barcelona
- Hospital Universitario Gregorio Marañón
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Main
Arm Description
MVA HIV-B
Outcomes
Primary Outcome Measures
Local adverse event
Grade 3 or above local adverse event (pain, cutaneous reactions including induration)
Grade 3 or above systemic adverse event
Grade 3 or above systemic adverse event (temperature, chills, headache, nausea, vomiting, malaise, and myalgia)
Grade 3 or above other clinical or laboratory adverse event
Grade 3 or above other clinical or laboratory adverse event confirmed at examination or on repeat testing respectively
Event attributable to vaccine leading to discontinuation
Any event attributable to vaccine leading to discontinuation of the immunisation regimen
Primary immunogenicity parameters
The primary immunogenicity parameters will be quantitative or present/absent, and are cellular responses - CD8/CD4+ T cell responses (ELISPOT) at week 2, 4 and 12 following the immunisations
Secondary Outcome Measures
All grade 1 and 2 adverse events
Antibody responses
binding titration to the construct MVAB
binding titration to and neutralisation of vaccinia
cellular responses
CD8/CD4+ T cell responses (ELISPOT) at week 0
intracellular cytokine analysis at week 0, 2, 4 and 12
Full Information
NCT ID
NCT01923610
First Posted
August 13, 2013
Last Updated
March 20, 2017
Sponsor
Hospital Clinic of Barcelona
1. Study Identification
Unique Protocol Identification Number
NCT01923610
Brief Title
Safety and Immunological Response of a Boosting Dose of MVA-B in Healthy Volunteers After 4 Years of Receiving MVA-B
Official Title
Safety and Immunological Response of a Boosting Dose of MVA-B in Healthy Volunteers After 4 Years of Receiving MVA-B
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
September 2013 (Actual)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Clinic of Barcelona
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Low risk HIV infection, HIV Seronegativity, HIV Preventive Vaccine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Main
Arm Type
Experimental
Arm Description
MVA HIV-B
Intervention Type
Biological
Intervention Name(s)
Experimental
Intervention Description
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
Primary Outcome Measure Information:
Title
Local adverse event
Description
Grade 3 or above local adverse event (pain, cutaneous reactions including induration)
Time Frame
12 weeks
Title
Grade 3 or above systemic adverse event
Description
Grade 3 or above systemic adverse event (temperature, chills, headache, nausea, vomiting, malaise, and myalgia)
Time Frame
12 weeks
Title
Grade 3 or above other clinical or laboratory adverse event
Description
Grade 3 or above other clinical or laboratory adverse event confirmed at examination or on repeat testing respectively
Time Frame
12 weeks
Title
Event attributable to vaccine leading to discontinuation
Description
Any event attributable to vaccine leading to discontinuation of the immunisation regimen
Time Frame
12 weeks
Title
Primary immunogenicity parameters
Description
The primary immunogenicity parameters will be quantitative or present/absent, and are cellular responses - CD8/CD4+ T cell responses (ELISPOT) at week 2, 4 and 12 following the immunisations
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
All grade 1 and 2 adverse events
Time Frame
28 days of vaccination
Title
Antibody responses
Description
binding titration to the construct MVAB
binding titration to and neutralisation of vaccinia
Time Frame
12 weeks
Title
cellular responses
Description
CD8/CD4+ T cell responses (ELISPOT) at week 0
intracellular cytokine analysis at week 0, 2, 4 and 12
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
male or female
age between 18 and 55 years on the day of screening
available for follow-up for the duration of the study (52 weeks from screening)
able to give written informed consent
at low risk of HIV and willing to remain so for the duration of the study low risk of HIV infection defined as: no history of injecting drug use in the previous ten years no gonorrhoea or syphilis in the last six months no high risk partner (e.g. injecting drug use, HIV positive partner) either currently or within the past six months no unprotected anal intercourse in the last six months no unprotected vaginal intercourse outside a relationship with a regular known/presumed HIV negative partner in the last six months
willing to undergo a HIV test
willing to undergo a genital infection screen
if heterosexually active female, using an effective method of contraception with partner (combined oral contraceptive pill; injectable contraceptive; 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
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:
positive for hepatitis B surface antigen, hepatitis C antibody, antibody responses to vaccinia or serology indicating active syphilis requiring treatment
pregnant or lactating
clinically relevant abnormality on history or examination including history of grand-mal epilepsy, severe eczema, immunodeficiency or use of immunosuppressives in preceding 3 months
receipt of live attenuated vaccine within 60 days or other vaccine within 14 days of enrolment
receipt of blood products or immunoglobin within 4 months of screening
participation in another trial of a medicinal product, completed less than 30 days prior to enrolment
history of severe local or general reaction to vaccination defined as local: extensive, indurated redness and swelling involving most of the front-lateral thigh or the major circumference of the arm, not resolving within 72 hours general: fever >= 39.5oC within 48 hours; anaphylaxis; bronchospasm; laryngeal
HIV 1/2 positive or indeterminate on screening
positive for hepatitis B surface antigen, hepatitis C antibody or serology indicating active syphilis requiring treatment
grade 1 routine laboratory parameters
unlikely to comply with protocol
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Felipe Garcia, MD
Organizational Affiliation
Hospital Clínic i Provincial de Barcelona
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Clínic i Provincial de Barcelona
City
Barcelona
State/Province
Catalunya
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Universitario Gregorio Marañón
City
Madrid
ZIP/Postal Code
28007
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
29065142
Citation
Guardo AC, Gomez CE, Diaz-Brito V, Pich J, Arnaiz JA, Perdiguero B, Garcia-Arriaza J, Gonzalez N, Sorzano COS, Jimenez L, Jimenez JL, Munoz-Fernandez MA, Gatell JM, Alcami J, Esteban M, Lopez Bernaldo de Quiros JC, Garcia F, Plana M; RISVAC02boost study. Safety and vaccine-induced HIV-1 immune responses in healthy volunteers following a late MVA-B boost 4 years after the last immunization. PLoS One. 2017 Oct 24;12(10):e0186602. doi: 10.1371/journal.pone.0186602. eCollection 2017. Erratum In: PLoS One. 2018 Apr 10;13(4):e0195915.
Results Reference
derived
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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
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