HIVPhase 1NCT01509144
EuroNeut41: Safety & Immunogenicity of Immunisations With HIV Vaccine
A Phase 1 study testing EN41-FPA2 HIV vaccine in people with HIV, run by PX'Therapeutics at 1 site in United Kingdom.
Trial summary
Objectives: To assess the safety of three priming immunisations by nasal route followed by two booster immunisations by intramuscular route To assess immunogenicity responses induced by the vaccine. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV
- What is being tested?
- EN41-FPA2 HIV vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2012to Oct 2013
- 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
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women aged between 18 and 55 years on the day of screening
- Available for a maximal study duration of 12/13 months from the inclusion
- Willing and able to give written informed consent
- At low risk of HIV infection and willing to remain so for the duration of the study defined as:
- no history of injecting drug use in the previous ten years
- no gonorrhoea or syphilis in the last six months
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- 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, outside a relationship with a regular partner known to be HIV negative
- no unprotected vaginal intercourse in the last six months outside a relationship with a regular known HIV negative partner
- not had unprotected sex with someone from a region where HIV is more common (e.g Sub-Saharan African, Caribbean, South East Asia) outside a relationship with a regular known HIV negative partner
- Negative HIV 1/2 antibody/antigen test at screening
- If heterosexually active female, using an effective method of contraception with partner (combined oral contraceptive pill; injectable or implanted contraceptive; use of condoms incorporating spermicide if using these; physiological or anatomical sterility) from 14 days prior to the first vaccination until 6 months after the last, and willing to undergo urine pregnancy tests prior to each vaccination and blood pregnancy test at screening and final follow up.
- Agree, to abstain from medications or other agents that are applied via the nasal route from 24 hours prior to each nasal vaccine dosing through to the safety assessment 1week later
- Agree to abstain from donating blood during their participation in the trial
- Registered with GP and medical history available for 12 months before dosing
- Satisfactory response received from General Practitioner relating to medical history before randomization.
Who cannot join
- Pregnant or lactating, or planning to get pregnant within the next year
- Positive alcohol test
- Positive drugs of abuse test
- Clinically relevant abnormality on history or examination:
- central nervous system disorder or disease, including
- history of grand-mal epilepsy
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- cranial nerve palsies
- severe eczema
- severe epistaxis requiring surgical intervention or blood transfusion
- clinically significant liver disease
- clinically significant haematological, metabolic, gastrointestinal, renal, psychiatric or cardio-pulmonary disorders
- ongoing infection;
- autoimmune disease, immunodeficiency or use of immunosuppressive agents in preceding 3 months prior to dosing
- using inhaled cortico-steroids and intranasal medications
- Known or suspected history of clinically relevant nasal surgery, injury, nasal polyps or cleft palate, or a condition likely to require regular intranasal medication, which in the opinion of the investigator might interfere with intranasal vaccine administration
- Known hypersensitivity to any component of the vaccine formulations used in this trial or have severe or multiple allergies
- History of severe local or general reaction to vaccination defined as
- local: extensive, indurated redness and swelling involving most of the antero-lateral thigh or the major circumference of the arm, not resolving within 72 hours
- general: fever > 39.5°C within 48 hours; anaphylaxis; bronchospasm; laryngeal oedema; collapse; convulsions or encephalopathy within 72 hours
- Receipt of live attenuated vaccine within 60 days or other vaccine within 14 days of scheduled study vaccine dosing
- Receipt of an experimental vaccine containing HIV envelope proteins at any time in the past
- Receipt of blood products or immunoglobin within 4 months of screening
- Participation in another trial of a medicinal product, completed less than 90 days prior to Visit 2 and planned participation in another clinical trial during the present trial
- HIV 1/2 antibody/antigen positive or indeterminate on screening
- Positive for hepatitis B surface antigen, hepatitis C antibody or serology indicating active syphilis requiring treatment
- Clinically significant routine laboratory parameters.
- Unable to read and speak English to a fluency level adequate for the full comprehension of procedures required in participation and consent.
- Unlikely to comply with protocol
- History of drug or alcohol abuse or regular using of drugs, or who test positive in drugs of abuse and alcohol test at screening or admission
- Has a condition, or is on regular medication (other than paracetamol, multivitamin, E45, or over the counter remedies) which in the opinion of the investigator is not suitable for participation in the study
- Any local vaginal, cervical or gynaecological condition which may interfere with collection or interpretation of data collected through vaginal samples.
- Using any Intra Uterine Contraceptive Device; as there is a risk of dislodging, displacing or removing the device when pulling or removing Softcup used for vaginal sampling.
- Clinically significant abnormality on ECG performed at the screening visit
- Any condition that, in the investigator's opinion, compromises the volunteer's ability to meet protocol requirements or to complete the study.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Surrey Clinical Research Centre University of Surrey
Guildford, Surrey, GU2 7XP
About this study
Official title: Phase 1, Randomised, Single-centre, Observer-blind Clinical Trial of Safety and Immunogenicity of Nasal-prime and Intramuscular Boost Immunisation With EN41-FPA2 HIV Vaccine in Healthy Female Volunteers
Objectives:
- To assess the safety of three priming immunisations by nasal route followed by two booster immunisations by intramuscular route
- To assess immunogenicity responses induced by the vaccine.
- Conditions
- HIV
- Being tested
- EN41-FPA2 HIV vaccine, Na Cl Placebo vaccine
- Keywords
- Safety of this HIV vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EN41-FPA2 HIV vaccineBiological
Group 1 Nasal vaccine - Low-dose (20 µg in 40 µL) IM vaccine (200 µg in 400 µL)
EN41-FPA2 HIV vaccineBiological
Group 2 Nasal vaccine - Mid-dose (100 µg in 200 µL) IM vaccine (200 µg in 400 µL)
EN41-FPA2 HIV vaccineBiological
Group 3 Nasal vaccine - Full-dose (200 µg in 400 µL) IM vaccine (200 µg in 400 µL)
EN41-FPA2 HIV vaccineBiological
Group 4 Nasal Placebo - 400 µL IM vaccine (200 µg in 400 µL)
Na Cl Placebo vaccineBiological
Group 5 Nasal placebo - 40 µL in Cohort 1 / 200 µL in Cohort 2 IM placebo (400 µL)
| Study group | Role | What they receive |
|---|---|---|
| nasal active low dose + IM active | Active comparator | Group 1 Nasal vaccine - Low-dose (20 µg in 40 µL) IM vaccine (200 µg in 400 µL) Receives: Biological: EN41-FPA2 HIV vaccine |
| nasal active mid dose + IM active | Active comparator | Group 2 Nasal vaccine - Mid-dose (100 µg in 200 µL) IM vaccine (200 µg in 400 µL) Receives: Biological: EN41-FPA2 HIV vaccine |
| nasal active full dose + IM active | Active comparator | Group 3 Nasal vaccine - Full-dose (200 µg in 400 µL) IM vaccine (200 µg in 400 µL) Receives: Biological: EN41-FPA2 HIV vaccine |
| nasal placebo + IM active | Active comparator | Group 4 Nasal Placebo - 400 µL IM vaccine (200 µg in 400 µL) Receives: Biological: EN41-FPA2 HIV vaccine |
| nasal placebo + IM placebo | Placebo comparator | Group 5 Nasal placebo - 40 µL in Cohort 1 / 200 µL in Cohort 2 IM placebo (400 µL) Receives: Biological: Na Cl Placebo vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
• Safety of 5 EN41-FPA2 immunisations Primary Endpoints: AEs and IgG and IgA responses to EN41-FPA2
•Safety - Grade 3 or above adverse event. Any grade of adverse event that results in a clinical decision to discontinue further immunisations - Any grade of adverse event that occurs in a volunteer that has received at least one immunisation • Immunogenicity: Proportion of individuals mounting a serum IgG response to EN41-FPA2 at any time point up to 28 days after the final immunisation with 3 fold increase from pre-immunisation baseline sample taken at visit 2, week 0, priming #1. If no serum sample is available at this time point, serum taken at visit 1, screening may be substituted."
Measured: up to 28 days after the final immunisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionJun 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- PX'Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- European Commission
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01509144
- Sponsor's protocol ID
- 2010-023693-39
- Status last verified
- May 2014
- First submitted
- 4 Jan 2012
- Last updated
- 21 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1, Randomised, Single-centre, Observer-blind Clinical Trial of Safety and Immunogenicity of Nasal-prime and Intramuscular Boost Immunisation With EN41-FPA2 HIV Vaccine in Healthy Female Volunteers
- ClinicalTrials.gov ID
- NCT01509144
- Acronym / sponsor ID
- 2010-023693-39
- Conditions
- HIV
- Keywords
- Safety of this HIV vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- PX'TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- European Commission
- Study start
- Jan 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 12 Jan 2012 (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.
Objectives:
- To assess the safety of three priming immunisations by nasal route followed by two booster immunisations by intramuscular route
- To assess immunogenicity responses induced by the vaccine.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| nasal active low dose + IM active | Active comparator | Biological: EN41-FPA2 HIV vaccineGroup 1 Nasal vaccine - Low-dose (20 µg in 40 µL) IM vaccine (200 µg in 400 µL) |
| nasal active mid dose + IM active | Active comparator | Biological: EN41-FPA2 HIV vaccineGroup 2 Nasal vaccine - Mid-dose (100 µg in 200 µL) IM vaccine (200 µg in 400 µL) |
| nasal active full dose + IM active | Active comparator | Biological: EN41-FPA2 HIV vaccineGroup 3 Nasal vaccine - Full-dose (200 µg in 400 µL) IM vaccine (200 µg in 400 µL) |
| nasal placebo + IM active | Active comparator | Biological: EN41-FPA2 HIV vaccineGroup 4 Nasal Placebo - 400 µL IM vaccine (200 µg in 400 µL) |
| nasal placebo + IM placebo | Placebo comparator | Biological: Na Cl Placebo vaccineGroup 5 Nasal placebo - 40 µL in Cohort 1 / 200 µL in Cohort 2 IM placebo (400 µL) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- Women aged between 18 and 55 years on the day of screening
- Available for a maximal study duration of 12/13 months from the inclusion
- Willing and able to give written informed consent
- At low risk of HIV infection and willing to remain so for the duration of the study defined as:
- Negative HIV 1/2 antibody/antigen test at screening
Key exclusion criteria (34 listed)
- Pregnant or lactating, or planning to get pregnant within the next year
- Positive alcohol test
- Positive drugs of abuse test
- Clinically relevant abnormality on history or examination:
- Known or suspected history of clinically relevant nasal surgery, injury, nasal polyps or cleft palate, or a condition likely to require regular intranasal medication, which in the opinion of the investigator might interfere with intranasal vaccine administration
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 |
|---|---|---|
| EN41-FPA2 HIV vaccineGroup 1 Nasal vaccine - Low-dose (20 µg in 40 µL) IM vaccine (200 µg in 400 µL) | Biological | nasal active low dose + IM active |
| EN41-FPA2 HIV vaccineGroup 2 Nasal vaccine - Mid-dose (100 µg in 200 µL) IM vaccine (200 µg in 400 µL) | Biological | nasal active mid dose + IM active |
| EN41-FPA2 HIV vaccineGroup 3 Nasal vaccine - Full-dose (200 µg in 400 µL) IM vaccine (200 µg in 400 µL) | Biological | nasal active full dose + IM active |
| EN41-FPA2 HIV vaccineGroup 4 Nasal Placebo - 400 µL IM vaccine (200 µg in 400 µL) | Biological | nasal placebo + IM active |
| Na Cl Placebo vaccineGroup 5 Nasal placebo - 40 µL in Cohort 1 / 200 µL in Cohort 2 IM placebo (400 µL) | Biological | nasal placebo + IM placebo |
Primary outcome
• Safety of 5 EN41-FPA2 immunisations Primary Endpoints: AEs and IgG and IgA responses to EN41-FPA2
Time frame: up to 28 days after the final immunisation
•Safety - Grade 3 or above adverse event. Any grade of adverse event that results in a clinical decision to discontinue further immunisations - Any grade of adverse event that occurs in a volunteer that has received at least one immunisation • Immunogenicity: Proportion of individuals mounting a serum IgG response to EN41-FPA2 at any time point up to 28 days after the final immunisation with 3 fold increase from pre-immunisation baseline sample taken at visit 2, week 0, priming #1. If no serum sample is available at this time point, serum taken at visit 1, screening may be substituted."
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 21 May 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 EN41-FPA2 HIV vaccine in people with HIV, run by PX'Therapeutics 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 16 inclusion and 34 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 21 May 2014. 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 5 EN41-FPA2 immunisations Primary Endpoints: AEs and IgG and IgA responses to EN41-FPA2 (time frame: up to 28 days after the final immunisation). 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 21 May 2014.