HIV InfectionsPhase 1NCT00369031
Safety Study Of Nasal HIV Vaccine Adjuvanted With LTK63
A Phase 1 study testing Human Immunodeficiency Virus glycoprotein 140 (vaccine), HIV glycoprotein 140 + Labile Toxin mutant LTK63 adjuvant and Labile Toxin mutant LTK63 adjuvant in people with HIV Infections, run by St George's, University of London at 1 site in United Kingdom.
Trial summary
The purpose of this study is to determine whether an HIV vaccine given as three nasal immunisations with a protein from HIV virus mixed with a toxoid adjuvant, followed by two intramuscular immunisations with the same protein mixed with a liquid adjuvant, causes untoward adverse reactions when administered to healthy… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- Human Immunodeficiency Virus glycoprotein 140 (vaccine), HIV glycoprotein 140 + Labile Toxin mutant LTK63 adjuvant and Labile Toxin mutant LTK63 adjuvant
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2006to Mar 2008
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- They are adult volunteers, 18 to 45 years of age, who have signed an informed consent form following a detailed written explanation of participation in the protocol.
- They are volunteers who are in good health as determined by medical history, physical examination and clinical judgement.
- They are available for the duration of the study
- They are women who, if capable of becoming pregnant during the study, have agreed to have a pregnancy test immediately before immunisation, and to use appropriate contraception methods during the whole study period.
Who cannot join
- They have hypersensitivity to any component of the vaccines used in this study.
- They are found to be HIV antibody positive at the time of initial screening
- They have a known or suspected history of nasal disease, malignancy or abnormality, or any nasal disease, malignancy or abnormality discovered at time of screening.
- They have a known or suspected history of severe seasonal allergies and allergic rhinitis (requiring medication), recurrent nose bleeds, asthma, or cardio-pulmonary disease, or any of these conditions discovered at time of screening.
- They present in the samples obtained at the screening visit:
- a clinically significant amount of protein or haemoglobin in the urine sample, determined by urine dipstick:
Show all 17Show fewer
- a clinically significant abnormality in the haematological or biochemical assays
- An abnormal value will be defined by the ranges quoted in the St George's Pathology Services Handbook.
- They have a known impairment of immune function or are receiving immunosuppressive therapy (including systemic or inhaled steroids, but excluding topical).
- They are receiving any medications via nasal route.
- They have any acute infections (including fever greater than or equal to 38°C) or any chronic disease.
- They are women capable of becoming pregnant who do not agree to have pregnancy testing before application of study products, or who do not agree to take appropriate contraception measures during the whole study period. Appropriate contraception shall include physician-prescribed oral, injected or implanted hormonal agents; barrier contraceptives used in conjunction with spermicidal agents; or intrauterine devices only.
- They present a current problem with substance abuse or with a history of substance abuse which, in the opinion of the investigator, might interfere with participation in the study.
- They have any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
- They have received an investigational agent within 3 months prior to study entry.
- They cannot speak fluent English, or are planning to leave the area of the study site prior to the end of the study period, or are likely not to complete the study.
- They have a weight (W)/height (H) index (WHI) less than 18.5 or greater than 40
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
St George's Vaccine Institute
London, England, SW17 0RE
About this study
Official title: A Phase I, Open Label, Parallel Group Trial To Evaluate Safety And Immunogenicity Of Three Nasal Immunisations Using A Fixed Dose-Level Of HIV gp140 V2 Loop Deleted Protein Adjuvanted With LTK63 Followed By Intramuscular Boosting With HIV gp140 V2 Loop Deleted Protein Adjuvanted With MF59 When Administered To Healthy Adults
The purpose of this study is to determine whether an HIV vaccine given as three nasal immunisations with a protein from HIV virus mixed with a toxoid adjuvant, followed by two intramuscular immunisations with the same protein mixed with a liquid adjuvant, causes untoward adverse reactions when administered to healthy adult volunteers. An initial evaluation of immune responses to the vaccine will also be undertaken.
Read the detailed description
The purpose of this study is to determine whether an HIV vaccine given as three nasal immunisations with a protein from HIV virus mixed with a toxoid adjuvant, followed by two intramuscular immunisations with the same protein mixed with a liquid adjuvant, causes untoward adverse reactions when administered to healthy adult volunteers. An initial evaluation of immune responses to the vaccine will also be undertaken by measuring gp140- and LTK63-specific IgG and IgA in cervical secretions, vaginal secretions, serum and nasal wash. IFNg secretion of T cells in response to gp140 peptide stimulation will be undertaken along with neutralising assays.
- Conditions
- HIV Infections
- Being tested
- Human Immunodeficiency Virus glycoprotein 140 (vaccine), HIV glycoprotein 140 + Labile Toxin mutant LTK63 adjuvant, Labile Toxin mutant LTK63 adjuvant
- Keywords
- HIV, vaccine, nasal immunization
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human Immunodeficiency Virus glycoprotein 140 (vaccine)Biological
Human Immunodeficiency Virus glycoprotein 140 (vaccine) alone nasally
HIV glycoprotein 140 + Labile Toxin mutant LTK63 adjuvantBiological
Human Immunodeficiency Virus glycoprotein 140 (vaccine) + Labile Toxin mutant LTK63 adjuvant nasally
Labile Toxin mutant LTK63 adjuvantBiological
Labile Toxin mutant LTK63 adjuvant alone
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Human Immunodeficiency Virus glycoprotein 140 (vaccine) Receives: Biological: Human Immunodeficiency Virus glycoprotein 140 (vaccine) |
| 2 | Active comparator | Human Immunodeficiency Virus glycoprotein 140 (vaccine) + Labile Toxin mutant LTK63 adjuvant Receives: Biological: HIV glycoprotein 140 + Labile Toxin mutant LTK63 adjuvant |
| 3 | Active comparator | Labile Toxin mutant LTK63 adjuvant Receives: Biological: Labile Toxin mutant LTK63 adjuvant |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the frequency of vaccine-related local and systemic adverse events after nasal immunisation up to week 32
Measured: 32 weeks
Secondary outcomes (6)
To determine the frequency of vaccine-related local and systemic adverse events after intramuscular immunization up to week 32
Measured: 32 weeks
To determine the frequency of subjects mounting a serum IgG neutralising antibody response to gp140 at weeks 0, 4, 8, 10, 12, 16, 28 & 32
Measured: 32 weeks
To determine the frequency of subjects mounting a nasal wash gp140-specific IgA response to gp140 at weeks 0, 4, 8, 10, 12, 16, 28 & 32
Measured: 32 weeks
To determine the frequency of female subjects mounting a vaginal secretions IgA response to gp140 at weeks 0, 4, 8, 10, 12, 16, 28 & 32
Measured: 32 weeks
To determine the frequency of subjects with a serum T-cell response to gp140 at weeks 0, 4, 8, 10, 12, 16, 28 & 32
Measured: 32 weeks
To determine frequency of subjects mounting a serum IgG response, nasal IgA response and vaginal IgA response to LTK63 at weeks 0, 4, 8, 10, 12, 16, 28 & 32
Measured: 32 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2006 (estimated)
- Study startSep 2006
- Primary completionNov 2007
- Study completionMar 2008
Why it stopped: Safety issues
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- St George's, University of London
- Sponsor type
- University, hospital or other
- Collaborators
- Richmond Pharmacology Limited, Novartis Vaccines, European Union
- Investigators
- David JM Lewis, MD, Principal investigator, St George's, University of London, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00369031
- Sponsor's protocol ID
- 2005-005983-10
- Other IDs
- C86P1, FP6-2002-LIFESCIHEA-2.3 503240, 2005
- Status last verified
- Apr 2008
- First submitted
- 24 Aug 2006
- Last updated
- 15 Apr 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open Label, Parallel Group Trial To Evaluate Safety And Immunogenicity Of Three Nasal Immunisations Using A Fixed Dose-Level Of HIV gp140 V2 Loop Deleted Protein Adjuvanted With LTK63 Followed By Intramuscular Boosting With HIV gp140 V2 Loop Deleted Protein Adjuvanted With MF59 When Administered To Healthy Adults
- ClinicalTrials.gov ID
- NCT00369031
- Acronym / sponsor ID
- 2005-005983-10
- Conditions
- HIV Infections
- Keywords
- HIV, vaccine, nasal immunization
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Safety issues
- Enrolment
- 31 participants (actual)
- Lead sponsor
- St George's, University of LondonUniversity, hospital or other
- Collaborators
- Richmond Pharmacology Limited, Novartis Vaccines, European Union
- Study start
- Sep 2006
- Primary completion
- Nov 2007 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 29 Aug 2006 (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 determine whether an HIV vaccine given as three nasal immunisations with a protein from HIV virus mixed with a toxoid adjuvant, followed by two intramuscular immunisations with the same protein mixed with a liquid adjuvant, causes untoward adverse reactions when administered to healthy adult volunteers. An initial evaluation of immune responses to the vaccine will also be undertaken.
Detailed description
The purpose of this study is to determine whether an HIV vaccine given as three nasal immunisations with a protein from HIV virus mixed with a toxoid adjuvant, followed by two intramuscular immunisations with the same protein mixed with a liquid adjuvant, causes untoward adverse reactions when administered to healthy adult volunteers. An initial evaluation of immune responses to the vaccine will also be undertaken by measuring gp140- and LTK63-specific IgG and IgA in cervical secretions, vaginal secretions, serum and nasal wash. IFNg secretion of T cells in response to gp140 peptide stimulation will be undertaken along with neutralising assays.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: Human Immunodeficiency Virus glycoprotein 140 (vaccine)Human Immunodeficiency Virus glycoprotein 140 (vaccine) |
| 2 | Active comparator | Biological: HIV glycoprotein 140 + Labile Toxin mutant LTK63 adjuvantHuman Immunodeficiency Virus glycoprotein 140 (vaccine) + Labile Toxin mutant LTK63 adjuvant |
| 3 | Active comparator | Biological: Labile Toxin mutant LTK63 adjuvantLabile Toxin mutant LTK63 adjuvant |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- They are adult volunteers, 18 to 45 years of age, who have signed an informed consent form following a detailed written explanation of participation in the protocol.
- They are volunteers who are in good health as determined by medical history, physical examination and clinical judgement.
- They are available for the duration of the study
- They are women who, if capable of becoming pregnant during the study, have agreed to have a pregnancy test immediately before immunisation, and to use appropriate contraception methods during the whole study period.
Key exclusion criteria (17 listed)
- They have hypersensitivity to any component of the vaccines used in this study.
- They are found to be HIV antibody positive at the time of initial screening
- They have a known or suspected history of nasal disease, malignancy or abnormality, or any nasal disease, malignancy or abnormality discovered at time of screening.
- They have a known or suspected history of severe seasonal allergies and allergic rhinitis (requiring medication), recurrent nose bleeds, asthma, or cardio-pulmonary disease, or any of these conditions discovered at time of screening.
- They present in the samples obtained at the screening visit:
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 |
|---|---|---|
| Human Immunodeficiency Virus glycoprotein 140 (vaccine)Human Immunodeficiency Virus glycoprotein 140 (vaccine) alone nasally | Biological | 1 |
| HIV glycoprotein 140 + Labile Toxin mutant LTK63 adjuvantHuman Immunodeficiency Virus glycoprotein 140 (vaccine) + Labile Toxin mutant LTK63 adjuvant nasally | Biological | 2 |
| Labile Toxin mutant LTK63 adjuvantLabile Toxin mutant LTK63 adjuvant alone | Biological | 3 |
Primary outcome
To determine the frequency of vaccine-related local and systemic adverse events after nasal immunisation up to week 32
Time frame: 32 weeks
6 secondary outcomes
To determine the frequency of vaccine-related local and systemic adverse events after intramuscular immunization up to week 32
Time frame: 32 weeks
To determine the frequency of subjects mounting a serum IgG neutralising antibody response to gp140 at weeks 0, 4, 8, 10, 12, 16, 28 & 32
Time frame: 32 weeks
To determine the frequency of subjects mounting a nasal wash gp140-specific IgA response to gp140 at weeks 0, 4, 8, 10, 12, 16, 28 & 32
Time frame: 32 weeks
To determine the frequency of female subjects mounting a vaginal secretions IgA response to gp140 at weeks 0, 4, 8, 10, 12, 16, 28 & 32
Time frame: 32 weeks
To determine the frequency of subjects with a serum T-cell response to gp140 at weeks 0, 4, 8, 10, 12, 16, 28 & 32
Time frame: 32 weeks
To determine frequency of subjects mounting a serum IgG response, nasal IgA response and vaginal IgA response to LTK63 at weeks 0, 4, 8, 10, 12, 16, 28 & 32
Time frame: 32 weeks
Results and safety
The study was stopped early (reason given: Safety issues). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2008.
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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.
David JM Lewis, MD principal investigator
St George's, University of London, UK
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 Human Immunodeficiency Virus glycoprotein 140 (vaccine), HIV glycoprotein 140 + Labile Toxin mutant LTK63 adjuvant and Labile Toxin mutant LTK63 adjuvant in people with HIV Infections, run by St George's, University of London 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 4 inclusion and 17 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: stopped early, as of the sponsor's last update on 15 Apr 2008. 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. 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 was stopped early (reason given: Safety issues). Results are not available in the source record.
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?
To determine the frequency of vaccine-related local and systemic adverse events after nasal immunisation up to week 32 (time frame: 32 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Apr 2008.