HIV InfectionsPhase 1NCT00902824

Safety and Immunogenicity of TBC-M4, a MVA HIV Vaccine Alone or in a Prime-Boost Regimen With ADVAX DNA HIV Vaccine

A Phase 1 study testing ADVAX and TBC-M4 in people with HIV Infections, run by International AIDS Vaccine Initiative at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This trial will study a prime-boost vaccine approach designed mainly to induce cell-mediated immune (CTL) responses. Read more about this study

Who is it for?: Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for: HIV Infections
What is being tested?: ADVAX and TBC-M4
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 32 participants
Where: 1 siteUnited Kingdom
Study dates: Nov 2008to Apr 2010
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 50 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

At least 18 years of age on the day of screening and no greater than 50 years (i.e., had not reached his/her 51st birthday) on the day of first vaccination;
Willing to comply with the requirements of the protocol and available for follow-up for the planned duration of the study;
In the opinion of the Principal Investigator or designee, has understood the information provided. Written informed consent needs to be given before any study-related procedures are performed;
Willing to undergo HIV Testing, HIV counselling and receive HIV test results;
If sexually active female, using an effective method of contraception (hormonal contraceptive; diaphragm; intrauterine device (IUD); condoms; anatomical sterility in self or partner) from screening until at least 4 months after last vaccination. All female volunteers must be willing to undergo urine pregnancy tests at time points as indicated in the Schedule of Procedures (Appendix A);
If sexually active male, willing to use an effective method of contraception (such as condoms, anatomical sterility) from the day of enrolment until at least 4 months after the last vaccination;
Willing to forgo donations of blood, sperm, eggs, bone marrow or organs during the study.

Who cannot join

Confirmed HIV-1 or HIV-2 infection;
High-risk behaviour for HIV infection which is defined as (Within 6 months before vaccination, the volunteer has):
Had unprotected vaginal or anal sex with a known HIV infected person or a casual partner (i.e., no continuing established relationship)
Engaged in sex work for money or drugs
Substance abuse/use injection drugs
Acquired a sexually transmitted disease (STD) (e.g., gonorrhoea, chlamydia, syphilis, Trichomonas vaginalis, and symptomatic herpes genitalis)

Show all 56Show fewer

Having a high-risk partner either currently or within the previous 6 months
Any clinically significant abnormality on history or examination including history of immunodeficiency or autoimmune disease; use of systemic corticosteroids, immunosuppressive, antiviral, anticancer, or other medications considered significant by the investigator within the previous 6 months; (Note: use of inhaled steroids for asthma and use of topical steroids for localized skin conditions will not exclude a volunteer from participation.)
Any clinically significant acute or chronic medical condition that is considered progressive or in the opinion of the investigator would make the volunteer unsuitable for the study;
Any of the following abnormal laboratory parameters listed below:
Haemoglobin <10.0 g/dL
Absolute Neutrophil Count (ANL): <1,000/mm3
Absolute Lymphocyte Count (ALC): <600/mm3
Platelets: <100,000/mm3
Creatinine: >1.3 x ULN
AST: >2.5 x ULN
ALT: >2.5 x ULN
Cardiac Troponin I: > ULN
Urinalysis: Abnormal dipstick confirmed by microscopy:
blood = 3+ or more (not due to menses)
protein = 3+ or more
leucocytes = 3+ or more
Confirmed diagnosis of hepatitis B (HBsAg), hepatitis C (HCV antibodies), or active syphilis;
If female, pregnant or planning a pregnancy within 4 months after last vaccination; or lactating;
Receipt of live attenuated vaccine within the previous 60 days (live attenuated flu vaccine within 14 days) or planned receipt within 60 days after vaccination with Investigational Product or receipt of other vaccine within the previous 14 days or planned receipt within 14 days after vaccination with Investigational Product;
Receipt of blood transfusion or blood products within the previous 6 months.
Participation in another clinical study of an investigational product currently, within the previous 3 months or expected participation during this study;
Receipt of another investigational HIV vaccine in the last 6 years (note: receipt of an HIV vaccine placebo will not exclude a subject from participation if documentation is available to the study site and the IAVI Medical Monitor gives approval);
History of severe local or systemic reactogenicity to vaccines or history of severe allergic reactions;
Major psychiatric illness including any history of schizophrenia or severe psychosis, bipolar disorder requiring therapy, suicidal attempt or ideation in the previous 3 years;
Smallpox vaccination within the previous 3 years;
ECG with clinically significant findings or features that would interfere with the assessment of myopericarditis, including but not limited to:
Conduction disturbance (atrio-ventricular or intra-ventricular conduction, left or right bundle branch block, AV block of any degree, or QTc prolongation)
Repolarization (ST segment or T wave) abnormality
Significant atrial or ventricular arrhythmia
Frequent atrial or ventricular arrhythmia
Frequent atrial or ventricular ectopy (e.g., frequent premature atrial contractions, two premature ventricular contractions in a row)
ST elevation consistent with ischemia
Evidence of past or evolving myocardial infarction (heart attack).
History of, or known active cardiac disease, including but not limited to:
Previous myocardial infarction
Angina pectoris
Congestive heart failure
Valvular heart disease, including mitral valve prolapse
Cardiomyopathy
Pericarditis
Stroke or transient ischemic attack
Chest pain or shortness of breath with activity (such as walking up stairs)
Other heart conditions under the care of a doctor.
Have 3 or more of the following risk factors:
High blood pressure diagnosed by a doctor
High blood cholesterol diagnosed by a doctor
Diabetes
High blood sugar diagnosed by a doctor
First degree relative (e.g., mother, father, brother, sister) who had a heart condition before the age of 50
Smoke cigarettes now.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

St Stephen's Centre Chelsea and Westminster Hospital
London, London, SW10 9NH

Other trials in United Kingdom

About this study

Official title: Phase I Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety and Immunogenicity of TBC-M4 (MVA Based HIV Vaccine) Alone or in a Prime-Boost Regimen With ADVAX, DNA HIV Vaccine

This trial will study a prime-boost vaccine approach designed mainly to induce cell-mediated immune (CTL) responses.

Read the detailed description

Two vaccine candidates will be used in two different prime-boost regimens: ADVAX (DNA) + TBC-M4 (MVA) and TBC-M4 (MVA) alone. Both these vaccines have already been tested in humans and both were found to be well tolerated and immunogenic. Approximately 32 volunteers (24 vaccine /8 placebo recipients) will be included in the study.

Conditions: HIV Infections
Being tested: ADVAX, TBC-M4, Placebo
Keywords: HIV
Medical subject headings: HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ADVAXBiological
Receive 4mg ADVAX at Months 0, 1, and 2 (Biojector), and receive boost of 5x10^7 pfu TBC-M4 (IM)
TBC-M4Biological
Receive 5x10^7 pfu TBC-M4 (IM) at Months 0, 1, and 6.
PlaceboOther
Group A (n=4) will receive the ADVAX placebo (formulation buffer) via Biojector.
Group B (n=4) will receive the TBC-M4 placebo (formulation buffer) via IM.

Study groups in NCT00902824
Study group	Role	What they receive
Group A	Active comparator	ADVAX at 0,1 and 2 months followed by TBC-M4 at 6 months Number of volunteers: 12 Receives: Biological: ADVAX
Group B	Active comparator	TBC-M4 at 0,1,6 months Number of volunteers: 12 Receives: Biological: TBC-M4
Placebo	Placebo comparator	Both Groups A and B will have 4 volunteers each (8 total) that will receive a placebo. Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Safety of TBC-M4 alone or in a prime-boost regimen with ADVAX
Safety and tolerability of TBC-M4 alone (given im) or in a prime-boost regimen with ADVAX (administered by Biojector)
Measured: 12 months

Secondary outcomes (1)

Immunogenicity of TBM-M4 alone or in a prime-boost regimen with ADVAX
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2008Apr 2010

First posted15 May 2009 (estimated)
Study startNov 2008
Primary completionApr 2010
Study completionApr 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HIV InfectionsStudies 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: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00902824
Sponsor's protocol ID: IAVI P002
Status last verified: Feb 2013
First submitted: 13 May 2009
Last updated: 11 Feb 2013
Results posted: No
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder

All HIV Infections trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase I Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety and Immunogenicity of TBC-M4 (MVA Based HIV Vaccine) Alone or in a Prime-Boost Regimen With ADVAX, DNA HIV Vaccine
ClinicalTrials.gov ID: NCT00902824
Acronym / sponsor ID: IAVI P002
Conditions: HIV Infections
Keywords: HIV
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 32 participants (actual)
Lead sponsor: International AIDS Vaccine InitiativeResearch network
Study start: Nov 2008
Primary completion: Apr 2010 (actual)
Study completion: Apr 2010 (actual)
First posted: 15 May 2009 (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.

This trial will study a prime-boost vaccine approach designed mainly to induce cell-mediated immune (CTL) responses.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Group A	Active comparator	Biological: ADVAXADVAX at 0,1 and 2 months followed by TBC-M4 at 6 months Number of volunteers: 12
Group B	Active comparator	Biological: TBC-M4TBC-M4 at 0,1,6 months Number of volunteers: 12
Placebo	Placebo comparator	Other: PlaceboBoth Groups A and B will have 4 volunteers each (8 total) that will receive a placebo.

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (7 listed)

At least 18 years of age on the day of screening and no greater than 50 years (i.e., had not reached his/her 51st birthday) on the day of first vaccination;
Willing to comply with the requirements of the protocol and available for follow-up for the planned duration of the study;
In the opinion of the Principal Investigator or designee, has understood the information provided. Written informed consent needs to be given before any study-related procedures are performed;
Willing to undergo HIV Testing, HIV counselling and receive HIV test results;
If sexually active female, using an effective method of contraception (hormonal contraceptive; diaphragm; intrauterine device (IUD); condoms; anatomical sterility in self or partner) from screening until at least 4 months after last vaccination. All female volunteers must be willing to undergo urine pregnancy tests at time points as indicated in the Schedule of Procedures (Appendix A);

Key exclusion criteria (56 listed)

Confirmed HIV-1 or HIV-2 infection;
High-risk behaviour for HIV infection which is defined as (Within 6 months before vaccination, the volunteer has):
Any clinically significant abnormality on history or examination including history of immunodeficiency or autoimmune disease; use of systemic corticosteroids, immunosuppressive, antiviral, anticancer, or other medications considered significant by the investigator within the previous 6 months; (Note: use of inhaled steroids for asthma and use of topical steroids for localized skin conditions will not exclude a volunteer from participation.)
Any clinically significant acute or chronic medical condition that is considered progressive or in the opinion of the investigator would make the volunteer unsuitable for the study;
Any of the following abnormal laboratory parameters listed below:

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
ADVAXReceive 4mg ADVAX at Months 0, 1, and 2 (Biojector), and receive boost of 5x10^7 pfu TBC-M4 (IM)	Biological	Group A
TBC-M4Receive 5x10^7 pfu TBC-M4 (IM) at Months 0, 1, and 6.	Biological	Group B
PlaceboGroup A (n=4) will receive the ADVAX placebo (formulation buffer) via Biojector. Group B (n=4) will receive the TBC-M4 placebo (formulation buffer) via IM.	Other	Placebo

Primary outcome

Safety of TBC-M4 alone or in a prime-boost regimen with ADVAX
Time frame: 12 months
Safety and tolerability of TBC-M4 alone (given im) or in a prime-boost regimen with ADVAX (administered by Biojector)

1 secondary outcome

Immunogenicity of TBM-M4 alone or in a prime-boost regimen with ADVAX
Time frame: 12 months

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 11 Feb 2013.
International AIDS Vaccine InitiativeLink provided by the sponsor.

Related trials for HIV Infections

Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder

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.

Brian Gazzard, MD principal investigator

St. Stephen's Centre

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 ADVAX and TBC-M4 in people with HIV Infections, run by International AIDS Vaccine Initiative at 1 site in United Kingdom.

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 7 inclusion and 56 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 11 Feb 2013. 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 Kingdom. 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?

Safety of TBC-M4 alone or in a prime-boost regimen with ADVAX (time frame: 12 months). 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 NCT00902824.

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 11 Feb 2013.