HIV InfectionsPhase 1NCT01966900
The Safety and Immunogenicity of a Potential HIV Vaccine
A Phase 1 study testing CN54gp140 mixed with GLA-AF in people with HIV Infections, run by Imperial College London at 1 site in United Kingdom.
Trial summary
The potential HIV vaccine has two components: a protein immunogen based on the coat protein of HIV; and an adjuvant which enhances the vaccinee's response to the immunogen. The immunogen is CN54gp140, and the adjuvant is glucopyranosyl lipid adjuvant - aqueous formulation (GLA-AF). 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?
- CN54gp140 mixed with GLA-AF
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2013to Nov 2015
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy male or female, as assessed by medical history, physical exam, and laboratory tests;
- At least 18 years of age on the day of screening and has not reached his/her 46th 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;
- Willing and able to give written informed consent;
- Willing to undergo HIV testing, receive HIV test results and be committed to maintaining low risk behaviour for the trial duration;
- If a female who is sexually active with male partner(s), willing to use an effective method of contraception from screening until at least 4 months after the last study vaccination [e.g., hormonal contraceptives, consistent record with condoms, physiological or anatomical sterility in self or partner, but excluding intrauterine device (IUD) which would preclude the collection of cervico-vaginal secretions with Softcup];
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- All female volunteers must be willing to undergo urine pregnancy tests at time points indicated in the Schedule of Procedures (Appendices A-B) and must test negative prior to each study vaccination;
- All sexually active males (unless anatomically sterile or in a monogamous relationship with a female partner who uses a documented non-barrier method of birth control) must be willing to use an effective method of contraception (e.g., consistent condom use) from the day of first vaccination until at least 4 months after the last vaccination;
- Willing to forgo donations of blood or any other tissues during the study and, for those who test HIV-positive due to trial vaccination (vaccine-induced HIV seropositivity), until the anti-HIV antibody titres become undetectable.
- Registered with a general practitioner for at least the past three months
Who cannot join
- Confirmed HIV-1 or HIV-2 infection;
- Any clinically relevant abnormality on history or examination including history of immunodeficiency or autoimmune disease; use of systemic corticosteroids (the use of topical or inhaled steroids is permitted); immunosuppressive, anti-cancer, anti-tuberculosis or other medications considered significant by the investigator within the previous 6 months;
- Any clinically significant acute or chronic medical condition that is considered progressive, or in the opinion of the investigator, makes the volunteer unsuitable for participation in the study;
- Reported risky behaviour for HIV infection within the 6 months prior to vaccination as defined by: history of injecting drug use in the previous ten years; gonorrhoea or syphilis in the last six months; high risk partner (e.g. injecting drug use, HIV positive partner) either currently or within the past six months; unprotected anal intercourse in the last six months, outside a relationship with a regular partner known to be HIV negative; or unprotected vaginal intercourse in the last six months outside a relationship with a regular known/presumed HIV negative partner.
- Reported abnormal cervical cytology or previous or ongoing treatment for Cervical Intraepithelial Neoplasia;
- If female, pregnant or planning a pregnancy within 4 months after last study vaccination; or lactating;
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- Bleeding disorder that was diagnosed by a physician (e.g., factor deficiency, coagulopathy or platelet disorder that requires special precautions) (Note: A volunteer who states that he or she has easy bruising or bleeding, but does not have a formal diagnosis and has intramuscular injections and blood draws without any adverse experience, is eligible);
- History of splenectomy;
- Any of the following abnormal laboratory parameters listed below: haemoglobin <11.0 g/dL; absolute neutrophil count (ANC) ≤ 1.3 x 109/L; absolute lymphocyte count (ALC) ≤ 0.9 x 109/L; platelets ≤ 125 x 109/L; creatinine >1.1 x upper limit of normal (ULN); aspartate aminotransferase >1.25 x ULN; alanine aminotransferase >1.25 x ULN; clinically significant abnormal urinalysis dipstick confirmed by microscopy (protein 2+ or more, blood 2+ or more not due to menses); positive for hepatitis B surface antigen (HbsAg), hepatitis C (HCV antibodies) or active syphilis;
- Receipt of live-attenuated vaccine within the previous 60 days or planned receipt within 60 days after vaccination with Investigational Product; or receipt of other vaccine, allergy treatment with antigen injections or tuberculin skin test within the previous 14 days or planned receipt within 14 days after vaccination with Investigational Product;
- Receipt of blood transfusion or blood-derived products within the previous 3 months;
- Participation in another clinical trial of an Investigational Product currently, within the previous 3 months or expected participation during this study;
- Prior receipt of another investigational HIV vaccine candidate (Note: receipt of placebo in a previous HIV vaccine trial will not exclude a volunteer from participation if documentation is available);
- History of severe local or systemic reactogenicity to vaccines (e.g., anaphylaxis, respiratory difficulty, angioedema);
- Psychiatric condition that compromises safety of the volunteer and precludes compliance with the protocol. Specifically excluded are persons with psychoses within the past 3 years, ongoing risk for suicide, or history of suicide attempt or gesture within the past 3 years;
- Seizure disorder: a participant who has had a seizure in the last 3 years is excluded. (Not excluded: a participant with a history of seizures who has neither required medications nor had a seizure for 3 years.);
- If female, history of toxic shock syndrome (TSS), which would preclude the use of Softcup;
- If female, current use of intrauterine device (IUD), which would preclude the use of Softcup;
- If, in the opinion of the Principal Investigator, it is not in the best interest of the volunteer to participate in the trial.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
NIHR/Wellcome Trust Imperial Clinical Research Facility, Hammersmith Hospital, Imperial College Healthcare NHS Trust
London, W12 0HS
About this study
Official title: A Phase 1 Open-Labelled Trial to Evaluate the Safety and Immunogenicity of CN54gp140 in HIV-Uninfected, Healthy Volunteers
The potential HIV vaccine has two components: a protein immunogen based on the coat protein of HIV; and an adjuvant which enhances the vaccinee's response to the immunogen. The immunogen is CN54gp140, and the adjuvant is glucopyranosyl lipid adjuvant - aqueous formulation (GLA-AF).
We wish to assess the vaccine's safety and immunogenicity (the nature of the immune response stimulated by the vaccine) when it is given in two different dose regimens:
Read more
Group A: vaccinations at Months 0, 1, 2 and 6; and Group B: vaccinations at Months 0, 1, 2 and 12.
Each dose will be an intramuscular injection of 100 micrograms of CN54gp140 mixed with 5 micrograms of GLA-AF.
We will recruit only healthy, HIV-uninfected men and women. We will assess the safety of the vaccine by monitoring the occurrence of adverse events in the participants. We will assess the immunogenicity of the vaccine by monitoring the immune response to the vaccine in blood and in genital mucosal secretion samples.
- Conditions
- HIV Infections
- Being tested
- CN54gp140 mixed with GLA-AF
- Keywords
- Human immunodeficiency disease, HIV, Vaccine, CN54gp140, Glucopyranosyl lipid adjuvant, GLA, GLA-AF
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CN54gp140 mixed with GLA-AFBiological
Each vaccination an intramuscular injection of 100 micrograms CN54gp140 mixed with 5 micrograms GLA-AF
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Biological/Vaccine: CN54gp140 mixed with GLA-AF
Vaccination at Months 0, 1, 2 and 6; each vaccination an intramuscular injection of 100 micrograms CN54gp140 mixed with 5 micrograms GLA-AF Receives: Biological: CN54gp140 mixed with GLA-AF |
| Group B | Active comparator | Biological/Vaccine: CN54gp140 mixed with GLA-AF
Vaccination at Months 0, 1, 2 and 12; each vaccination an intramuscular injection of 100 micrograms CN54gp140 mixed with 5 micrograms GLA-AF Receives: Biological: CN54gp140 mixed with GLA-AF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Moderate or Greater Reactogenicity (i.e., Solicited Adverse Events)
Measured: 7 days
Number of Participants With Moderate or Greater and/or Vaccine-related Unsolicited Adverse Events (AEs)
Including safety laboratory (biochemical, haematological) parameters, from the day of each vaccination up to 28 days post each vaccination.
Measured: 28 days
Number of Participants With Vaccine Related Serious Adverse Events (SAEs) Collected Throughout the Study Period
Measured: 13 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- Wellcome Trust, National Institute for Health Research, United Kingdom
- Responsible party
- Sponsor
- Investigators
- Sarah Fidler, MD, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01966900
- Sponsor's protocol ID
- X001
- Status last verified
- Oct 2019
- First submitted
- 15 Oct 2013
- Last updated
- 7 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Anderson J, Olafsdottir TA, Kratochvil S, McKay PF, Ostensson M, Persson J, Shattock RJ, Harandi AM. Molecular Signatures of a TLR4 Agonist-Adjuvanted HIV-1 Vaccine Candidate in Humans. Front Immunol. 2018 Feb 26;9:301. doi: 10.3389/fimmu.2018.00301. eCollection 2018.
PubMed 29535712Kratochvil S, McKay PF, Kopycinski JT, Bishop C, Hayes PJ, Muir L, Pinder CL, Cizmeci D, King D, Aldon Y, Wines BD, Hogarth PM, Chung AW, Kent SJ, Held K, Geldmacher C, Dally L, Santos NS, Cole T, Gilmour J, Fidler S, Shattock RJ. A Phase 1 Human Immunodeficiency Virus Vaccine Trial for Cross-Profiling the Kinetics of Serum and Mucosal Antibody Responses to CN54gp140 Modulated by Two Homologous Prime-Boost Vaccine Regimens. Front Immunol. 2017 May 24;8:595. doi: 10.3389/fimmu.2017.00595. eCollection 2017.
PubMed 28596770
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Open-Labelled Trial to Evaluate the Safety and Immunogenicity of CN54gp140 in HIV-Uninfected, Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01966900
- Acronym / sponsor ID
- X001
- Conditions
- HIV Infections
- Keywords
- Human immunodeficiency disease, HIV, Vaccine, CN54gp140, Glucopyranosyl lipid adjuvant, GLA, GLA-AF
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- Wellcome Trust, National Institute for Health Research, United Kingdom
- Study start
- Oct 2013
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 22 Oct 2013 (estimated)
- Results
- Posted 7 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The potential HIV vaccine has two components: a protein immunogen based on the coat protein of HIV; and an adjuvant which enhances the vaccinee's response to the immunogen. The immunogen is CN54gp140, and the adjuvant is glucopyranosyl lipid adjuvant - aqueous formulation (GLA-AF).
We wish to assess the vaccine's safety and immunogenicity (the nature of the immune response stimulated by the vaccine) when it is given in two different dose regimens:
Group A: vaccinations at Months 0, 1, 2 and 6; and Group B: vaccinations at Months 0, 1, 2 and 12.
Each dose will be an intramuscular injection of 100 micrograms of CN54gp140 mixed with 5 micrograms of GLA-AF.
We will recruit only healthy, HIV-uninfected men and women. We will assess the safety of the vaccine by monitoring the occurrence of adverse events in the participants. We will assess the immunogenicity of the vaccine by monitoring the immune response to the vaccine in blood and in genital mucosal secretion samples.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Biological: CN54gp140 mixed with GLA-AFBiological/Vaccine: CN54gp140 mixed with GLA-AF Vaccination at Months 0, 1, 2 and 6; each vaccination an intramuscular injection of 100 micrograms CN54gp140 mixed with 5 micrograms GLA-AF |
| Group B | Active comparator | Biological: CN54gp140 mixed with GLA-AFBiological/Vaccine: CN54gp140 mixed with GLA-AF Vaccination at Months 0, 1, 2 and 12; each vaccination an intramuscular injection of 100 micrograms CN54gp140 mixed with 5 micrograms GLA-AF |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Healthy male or female, as assessed by medical history, physical exam, and laboratory tests;
- At least 18 years of age on the day of screening and has not reached his/her 46th 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;
- Willing and able to give written informed consent;
- Willing to undergo HIV testing, receive HIV test results and be committed to maintaining low risk behaviour for the trial duration;
Key exclusion criteria (19 listed)
- Confirmed HIV-1 or HIV-2 infection;
- Any clinically relevant abnormality on history or examination including history of immunodeficiency or autoimmune disease; use of systemic corticosteroids (the use of topical or inhaled steroids is permitted); immunosuppressive, anti-cancer, anti-tuberculosis or other medications considered significant by the investigator within the previous 6 months;
- Any clinically significant acute or chronic medical condition that is considered progressive, or in the opinion of the investigator, makes the volunteer unsuitable for participation in the study;
- Reported risky behaviour for HIV infection within the 6 months prior to vaccination as defined by: history of injecting drug use in the previous ten years; gonorrhoea or syphilis in the last six months; high risk partner (e.g. injecting drug use, HIV positive partner) either currently or within the past six months; unprotected anal intercourse in the last six months, outside a relationship with a regular partner known to be HIV negative; or unprotected vaginal intercourse in the last six months outside a relationship with a regular known/presumed HIV negative partner.
- Reported abnormal cervical cytology or previous or ongoing treatment for Cervical Intraepithelial Neoplasia;
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 |
|---|---|---|
| CN54gp140 mixed with GLA-AFEach vaccination an intramuscular injection of 100 micrograms CN54gp140 mixed with 5 micrograms GLA-AF | Biological | Group A, Group B |
Primary outcome
Number of Participants With Moderate or Greater Reactogenicity (i.e., Solicited Adverse Events)
Time frame: 7 days
Number of Participants With Moderate or Greater and/or Vaccine-related Unsolicited Adverse Events (AEs)
Time frame: 28 days
Including safety laboratory (biochemical, haematological) parameters, from the day of each vaccination up to 28 days post each vaccination.
Number of Participants With Vaccine Related Serious Adverse Events (SAEs) Collected Throughout the Study Period
Time frame: 13 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29535712Anderson J, Olafsdottir TA, Kratochvil S, McKay PF, Ostensson M, Persson J, Shattock RJ, Harandi AM. Molecular Signatures of a TLR4 Agonist-Adjuvanted HIV-1 Vaccine Candidate in Humans. Front Immunol. 2018 Feb 26;9:301. doi: 10.3389/fimmu.2018.00301. eCollection 2018.
- Derived from this study: PubMed 28596770Kratochvil S, McKay PF, Kopycinski JT, Bishop C, Hayes PJ, Muir L, Pinder CL, Cizmeci D, King D, Aldon Y, Wines BD, Hogarth PM, Chung AW, Kent SJ, Held K, Geldmacher C, Dally L, Santos NS, Cole T, Gilmour J, Fidler S, Shattock RJ. A Phase 1 Human Immunodeficiency Virus Vaccine Trial for Cross-Profiling the Kinetics of Serum and Mucosal Antibody Responses to CN54gp140 Modulated by Two Homologous Prime-Boost Vaccine Regimens. Front Immunol. 2017 May 24;8:595. doi: 10.3389/fimmu.2017.00595. eCollection 2017.
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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.
Sarah Fidler, MD principal investigator
Imperial College London
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 CN54gp140 mixed with GLA-AF in people with HIV Infections, run by Imperial College 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 10 inclusion and 19 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 7 Nov 2019. 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?
Yes. Results are posted in the registry (first posted 7 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Moderate or Greater Reactogenicity (i.e., Solicited Adverse Events) (time frame: 7 days). The study lists 3 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 NCT01966900, which also lists 2 linked publications.
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 7 Nov 2019.