HealthyPhase 1MENSCHNCT02218125
A Phase I Study of an HIV Vaccine in Healthy, HIV Uninfected Adults
A Phase 1 study testing MVA Mosaic in people with Healthy, run by Crucell Holland BV at 1 site in United States.
Trial summary
The purpose of this study is to assess the safety and tolerability of Modified Vaccinia Ankara (MVA) Mosaic vaccine in healthy adult participants. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- MVA Mosaic
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Sep 2014to 30 Nov 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults (determined by medical history, physical examination, and clinical judgment)
- HIV uninfected
- Female participants of child bearing potential must have a negative serum β-human chorionic gonadotrophin pregnancy test at the screening visit and immediately prior to each vaccine/placebo administration, practice adequate birth control measures from 28 days prior to the first vaccine/placebo administration through to at least 3 months after the final vaccine/placebo administration
- Male participants who are sexually active with a woman of childbearing potential and has not had a vasectomy must agree to use a double barrier method of birth control, e.g. either condom with spermicidal foam/gel/film/cream/suppository or partner with occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository
Who cannot join
- Confirmed HIV-1/-2 infection
- Chronic active hepatitis B or hepatitis C or active syphilis infection. Active syphilis documented by exam or serology unless positive serology is due to past treated infection
- Within the 12 months prior to enrollment: a history of newly acquired syphilis, gonorrhea, non-gonococcal urethritis, herpes simplex virus type 2 (HSV2), Chlamydia, pelvic inflammatory disease (PID), trichomonas, mucopurulent cervicitis, epididymitis, proctitis, lymphogranulomavenereum, chancroid, or hepatitis B
- A woman who is breastfeeding
- Any clinically significant acute or chronic medical condition that, in the opinion of the investigator, would preclude participation
- Major surgery within the 4 weeks prior to study entry or planned major surgery through the course of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Study of Modified Vaccinia Ankara With Mosaic HIV Inserts in Healthy, HIV-Uninfected Adults, Some of Whom Have Previously Received an Adenovirus Type 26 ENVA.01 Vaccine
The purpose of this study is to assess the safety and tolerability of Modified Vaccinia Ankara (MVA) Mosaic vaccine in healthy adult participants.
Read the detailed description
This is a Phase I, placebo-controlled (the use of an inactive substance identical in appearance to the active vaccine), double-blind (neither the participant or study personnel will know the identity of the treatment administered) study where participants will be randomized (treatment type assigned by chance) to receive a Modified Vaccinia Ankara (MVA) Mosaic vaccine (at 1x10E8 pfu) or placebo. This design is intended to reduce the likelihood of observer and selection bias, provide control for confounding variables, and aid an unbiased analysis of the study results. The study will include 4 groups of participants, 2 groups having previously been vaccinated with Ad26.ENVA.01 (A recombinant adenovirus [rAd] vaccine for HIV-1) and 2 groups not previously vaccinated with Ad26.ENVA.01. Participants will be randomized in a 4:1 ratio to receive either a MVA Mosaic vaccine or placebo. The trial comprises a 4-week screening period, a 12-week vaccination period during which participants will be vaccinated at baseline (Day 1) and Week 12 (Day 84), and a 40-week follow-up period to the final visit at Week 52.
- Conditions
- Healthy
- Being tested
- MVA Mosaic, Placebo
- Keywords
- Healthy, Human immunodeficiency virus type 1 (HIV-1) infection, Acquired immunodeficiency syndrome (AIDS), recombinant adenovirus (rAd) vector-based vaccines, Vaccination, Ad26.ENVA.01, Recombinant, Modified Vaccinia Ankara (MVA) vector-based vaccines
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Infections, Dyschromatosis symmetrica hereditaria 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MVA MosaicBiological
0.5 mL (1x10E8 pfu) MVA Mosaic (comprised of MVA Mosaic 1 and MVA Mosaic 2 mixed in a 1:1 ratio before administration) will be administered by intramuscular (IM) injection.
PlaceboBiological
0.5 mL Sodium Chloride Injection USP, 0.9%will be administered by intramuscular (IM) injection.
| Study group | Role | What they receive |
|---|---|---|
| Group 1- MVA Mosaic | Experimental | Healthy volunteers not previously vaccinated with Ad26.ENVA.01 will be administered Modified Vaccinia Ankara (MVA) Mosaic at Week 0 and at Week 12. Receives: Biological: MVA Mosaic |
| Group 2 - Placebo | Placebo comparator | Healthy volunteers not previously vaccinated with Ad26.ENVA.01 will be administered placebo at Week 0 and at Week 12. Receives: Biological: Placebo |
| Group 3 - MVA Mosaic | Experimental | Healthy volunteers previously vaccinated with Ad26.ENVA.01 will be administered MVA Mosaic at Week 0 and at Week 12. Receives: Biological: MVA Mosaic |
| Group 4- Placebo | Placebo comparator | Participants previously vaccinated with Ad26.ENVA.01 will be administered placebo at Week 0 and at Week 12. Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Number of Participants who Experience Adverse Events Within 28 days After Vaccination
In addition to the number of participants who experience adverse events within the time frame of 28 days after each vaccination, all adverse events that occur from the signing of the informed consent through to the last study visit (Visit 10 [Day 365]) will be reported.
Measured: For 28 days following vaccination on Day 1 and Day 84
The Number of Participants who Experience Reactogenicity Symptoms Following Vaccination
Reactogenicity symptoms monitored following vaccination will include erythema (redness), induration (hardening), and local pain/tenderness, itching, swelling, or warmth at the site of injection, temperature (fever >37.7 degree Celsius); fatigue (extreme tiredness), headache, myalgia (muscle pain), arthralgia (joint pain), chills, nausea, vomiting, rashes, and itching (general and local)
Measured: 1 week following vaccination on Day 1 and Day 84
Secondary outcomes (3)
The Number of Participants With Humoral Immune Responses
Humoral immune responses will be evaluated by the detection of env-specific binding antibody.
Measured: 4 weeks after the second vaccination
Durability of Immune Response
Determined by humoral immune response assays.
Measured: 6, 9, and 12 months after the first vaccination
The Number of Participants With T-cell Responses Following Vaccination
T-cell responses to be determined by epitope mapping.
Measured: 4 weeks after the second vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2014 (estimated)
- Study start23 Sep 2014
- Primary completion30 Nov 2015
- Study completion30 Nov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Crucell Holland BV
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- US Military HIV Research Program, National Institute of Allergy and Infectious Diseases (NIAID), Beth Israel Deaconess Medical Center
- Responsible party
- Sponsor
- Investigators
- Crucell Holland BV Clinical Trial, Study director, Crucell Holland BV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02218125
- Sponsor's protocol ID
- CR100965
- Other IDs
- IPCAVD006, HIV-V-A002
- Acronym
- MENSCH
- Status last verified
- Nov 2018
- First submitted
- 14 Aug 2014
- Last updated
- 27 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
Publications
Baden LR, Walsh SR, Seaman MS, Cohen YZ, Johnson JA, Licona JH, Filter RD, Kleinjan JA, Gothing JA, Jennings J, Peter L, Nkolola J, Abbink P, Borducchi EN, Kirilova M, Stephenson KE, Pegu P, Eller MA, Trinh HV, Rao M, Ake JA, Sarnecki M, Nijs S, Callewaert K, Schuitemaker H, Hendriks J, Pau MG, Tomaka F, Korber BT, Alter G, Dolin R, Earl PL, Moss B, Michael NL, Robb ML, Barouch DH; IPCAVD006/RV380/HIV-V-A002 Study Group. First-in-Human Randomized, Controlled Trial of Mosaic HIV-1 Immunogens Delivered via a Modified Vaccinia Ankara Vector. J Infect Dis. 2018 Jul 13;218(4):633-644. doi: 10.1093/infdis/jiy212.
PubMed 29669026
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Modified Vaccinia Ankara With Mosaic HIV Inserts in Healthy, HIV-Uninfected Adults, Some of Whom Have Previously Received an Adenovirus Type 26 ENVA.01 Vaccine
- ClinicalTrials.gov ID
- NCT02218125
- Acronym / sponsor ID
- MENSCH / CR100965
- Conditions
- Healthy
- Keywords
- Healthy, Human immunodeficiency virus type 1 (HIV-1) infection, Acquired immunodeficiency syndrome (AIDS), recombinant adenovirus (rAd) vector-based vaccines, Vaccination, Ad26.ENVA.01, Recombinant, Modified Vaccinia Ankara (MVA) vector-based vaccines
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Crucell Holland BVIndustry (pharma, biotech, devices)
- Collaborators
- US Military HIV Research Program, National Institute of Allergy and Infectious Diseases (NIAID), Beth Israel Deaconess Medical Center
- Study start
- 23 Sep 2014 (actual)
- Primary completion
- 30 Nov 2015 (actual)
- Study completion
- 30 Nov 2015 (actual)
- First posted
- 15 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the safety and tolerability of Modified Vaccinia Ankara (MVA) Mosaic vaccine in healthy adult participants.
Detailed description
This is a Phase I, placebo-controlled (the use of an inactive substance identical in appearance to the active vaccine), double-blind (neither the participant or study personnel will know the identity of the treatment administered) study where participants will be randomized (treatment type assigned by chance) to receive a Modified Vaccinia Ankara (MVA) Mosaic vaccine (at 1x10E8 pfu) or placebo. This design is intended to reduce the likelihood of observer and selection bias, provide control for confounding variables, and aid an unbiased analysis of the study results. The study will include 4 groups of participants, 2 groups having previously been vaccinated with Ad26.ENVA.01 (A recombinant adenovirus [rAd] vaccine for HIV-1) and 2 groups not previously vaccinated with Ad26.ENVA.01. Participants will be randomized in a 4:1 ratio to receive either a MVA Mosaic vaccine or placebo. The trial comprises a 4-week screening period, a 12-week vaccination period during which participants will be vaccinated at baseline (Day 1) and Week 12 (Day 84), and a 40-week follow-up period to the final visit at Week 52.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1- MVA Mosaic | Experimental | Biological: MVA MosaicHealthy volunteers not previously vaccinated with Ad26.ENVA.01 will be administered Modified Vaccinia Ankara (MVA) Mosaic at Week 0 and at Week 12. |
| Group 2 - Placebo | Placebo comparator | Biological: PlaceboHealthy volunteers not previously vaccinated with Ad26.ENVA.01 will be administered placebo at Week 0 and at Week 12. |
| Group 3 - MVA Mosaic | Experimental | Biological: MVA MosaicHealthy volunteers previously vaccinated with Ad26.ENVA.01 will be administered MVA Mosaic at Week 0 and at Week 12. |
| Group 4- Placebo | Placebo comparator | Biological: PlaceboParticipants previously vaccinated with Ad26.ENVA.01 will be administered placebo at Week 0 and at Week 12. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy adults (determined by medical history, physical examination, and clinical judgment)
- HIV uninfected
- Female participants of child bearing potential must have a negative serum β-human chorionic gonadotrophin pregnancy test at the screening visit and immediately prior to each vaccine/placebo administration, practice adequate birth control measures from 28 days prior to the first vaccine/placebo administration through to at least 3 months after the final vaccine/placebo administration
- Male participants who are sexually active with a woman of childbearing potential and has not had a vasectomy must agree to use a double barrier method of birth control, e.g. either condom with spermicidal foam/gel/film/cream/suppository or partner with occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository
Key exclusion criteria (6 listed)
- Confirmed HIV-1/-2 infection
- Chronic active hepatitis B or hepatitis C or active syphilis infection. Active syphilis documented by exam or serology unless positive serology is due to past treated infection
- Within the 12 months prior to enrollment: a history of newly acquired syphilis, gonorrhea, non-gonococcal urethritis, herpes simplex virus type 2 (HSV2), Chlamydia, pelvic inflammatory disease (PID), trichomonas, mucopurulent cervicitis, epididymitis, proctitis, lymphogranulomavenereum, chancroid, or hepatitis B
- A woman who is breastfeeding
- Any clinically significant acute or chronic medical condition that, in the opinion of the investigator, would preclude participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MVA Mosaic0.5 mL (1x10E8 pfu) MVA Mosaic (comprised of MVA Mosaic 1 and MVA Mosaic 2 mixed in a 1:1 ratio before administration) will be administered by intramuscular (IM) injection. | Biological | Group 1- MVA Mosaic, Group 3 - MVA Mosaic |
| Placebo0.5 mL Sodium Chloride Injection USP, 0.9%will be administered by intramuscular (IM) injection. | Biological | Group 2 - Placebo, Group 4- Placebo |
Primary outcome
The Number of Participants who Experience Adverse Events Within 28 days After Vaccination
Time frame: For 28 days following vaccination on Day 1 and Day 84
In addition to the number of participants who experience adverse events within the time frame of 28 days after each vaccination, all adverse events that occur from the signing of the informed consent through to the last study visit (Visit 10 [Day 365]) will be reported.
The Number of Participants who Experience Reactogenicity Symptoms Following Vaccination
Time frame: 1 week following vaccination on Day 1 and Day 84
Reactogenicity symptoms monitored following vaccination will include erythema (redness), induration (hardening), and local pain/tenderness, itching, swelling, or warmth at the site of injection, temperature (fever >37.7 degree Celsius); fatigue (extreme tiredness), headache, myalgia (muscle pain), arthralgia (joint pain), chills, nausea, vomiting, rashes, and itching (general and local)
3 secondary outcomes
The Number of Participants With Humoral Immune Responses
Time frame: 4 weeks after the second vaccination
Durability of Immune Response
Time frame: 6, 9, and 12 months after the first vaccination
The Number of Participants With T-cell Responses Following Vaccination
Time frame: 4 weeks after the second vaccination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2018.
- Derived from this study: PubMed 29669026Baden LR, Walsh SR, Seaman MS, Cohen YZ, Johnson JA, Licona JH, Filter RD, Kleinjan JA, Gothing JA, Jennings J, Peter L, Nkolola J, Abbink P, Borducchi EN, Kirilova M, Stephenson KE, Pegu P, Eller MA, Trinh HV, Rao M, Ake JA, Sarnecki M, Nijs S, Callewaert K, Schuitemaker H, Hendriks J, Pau MG, Tomaka F, Korber BT, Alter G, Dolin R, Earl PL, Moss B, Michael NL, Robb ML, Barouch DH; IPCAVD006/RV380/HIV-V-A002 Study Group. First-in-Human Randomized, Controlled Trial of Mosaic HIV-1 Immunogens Delivered via a Modified Vaccinia Ankara Vector. J Infect Dis. 2018 Jul 13;218(4):633-644. doi: 10.1093/infdis/jiy212.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Crucell Holland BV Clinical Trial study director
Crucell Holland BV
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MVA Mosaic in people with Healthy, run by Crucell Holland BV at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Number of Participants who Experience Adverse Events Within 28 days After Vaccination (time frame: For 28 days following vaccination on Day 1 and Day 84). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02218125, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2018.