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- HIVPhase 1NCT01827397

Safety & Immunogenicity of Immunisations With EN41-UGR7C HIV Vaccine

A Phase 1 study testing EN41-UGR7C HIV vaccine and NaCl in people with - HIV, run by PX'Therapeutics 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
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Trial summary

The purpose of the clinical trial is to evaluate the safety and immunogenicity in female volunteers of EN41-UGR7C vaccine candidate adjuvanted with Alum using IM administration. The objective of the immunisation is to induce mucosal and systemic binding and neutralizing antibodies against HIV in order to block the… 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-UGR7C HIV vaccine and NaCl
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
24 participants
Where
1 siteUnited Kingdom
Study dates
Apr 2013to Feb 2014
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 8 months from screening
  • 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 infected sexual partner) either currently or within the past six months
  • no unprotected vaginal or anal intercourse in the last six months outside a relationship with a regular partner known to be HIV negative
  • no unprotected sex with someone from a high HIV prevalence region where HIV is more common than in the UK (e.g. Sub-Saharan Africa, Caribbean, South-East Asia)
  • Negative HIV1/2 antibody/antigen test result at screening
  • If heterosexually active female, using an effective method of contraception using a double barrier method of contraception (combined oral contraceptive pill, injectable or implanted contraceptive and use of condoms incorporating spermicide; physiological or anatomical sterility) from 14 days prior to the first vaccine administration until 3 months after the last administration, and willing to undergo urine pregnancy tests prior to each vaccine administration and blood pregnancy test at screening and final follow-up visits. Heterosexual females who become sexually active during the trial should also follow the same guidance
  • Agree to abstain from donating blood during their participation in the trial
  • Registered with a General Practitioner 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
  • Clinically relevant abnormality on history or examination:
  • central nervous system disorder or disease, including history of grand-mal epilepsy
  • severe eczema
  • clinically significant haematological, cardio-pulmonary, metabolic, gastrointestinal, renal, psychiatric or ophthalmological disorders
  • acute infection or illness
Show all 26Show fewer
  • autoimmune disease, immunodeficiency or use of immunosuppressive agents in preceding 3 months prior to dosing
  • Known hypersensitivity to any component of the vaccine formulation used in this trial, or have severe or multiple allergies
  • History of severe local or general reaction to previous 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 schedules study vaccine dosing
  • Receipt of an experimental vaccine containing HIV envelope proteins at any time in the past
  • Receipt of blood products or immunoglobulin 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 abnormal result in routine laboratory parameters.
  • Unable to read and speak English to a fluency level adequate for the full comprehension of study and procedures required in participation and consent
  • Unlikely to comply with protocol
  • History of drug or alcohol abuse or regular use of drugs, or who test positive for alcohol test at screening
  • On regular medication which in the opinion of the investigator makes volunteer unsuitable 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

  • Royal Free Hospital; Royal Free London NHS Foundation Trust Pond Street

    London, NW3 2QG

Other trials in United Kingdom

About this study

Official title: Phase 1 Randomised, Single-centre, Observer-blind, Placebo-controlled Trial of Safety and Immunogenicity of EN41-UGR7C HIV Vaccine Candidate Administered Intramuscularly in Healthy Female Volunteers

The purpose of the clinical trial is to evaluate the safety and immunogenicity in female volunteers of EN41-UGR7C vaccine candidate adjuvanted with Alum using IM administration. The objective of the immunisation is to induce mucosal and systemic binding and neutralizing antibodies against HIV in order to block the virus on the mucosal surface and neutralise the viral particles that may eventually succeed in crossing the mucosal barrier.

This is a Phase 1 exploratory study. EN41-UGR7C will be administered for the first time in humans.

Read more

Volunteers who are vaccinated with EN41-UGR7C may develop an immune response against HIV, but its ability to induce meaningful protection against HIV will not be known before Phase 3 efficacy trials are completed, as correlates of protection against HIV are not yet clearly defined.

Consequently, there is no direct benefit to volunteers. They will be reimbursed for their time and travel.

Conditions
- HIV
Being tested
EN41-UGR7C HIV vaccine, NaCl
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-UGR7C HIV vaccineBiological

    Also called EN41-UGR7C adjuvanted with Alum

  • NaClBiological

    Also called NaCl placebo vaccine

Study groups in NCT01827397
Study groupRoleWhat they receive
EN41-UGR7C HIV vaccineExperimentalGroup 1: IM injection of 210 µg UGR7-C in 560 µg of Alum at month 0, 1 and 4
Receives: Biological: EN41-UGR7C HIV vaccine
NaClPlacebo comparatorGroup 2: IM injection of 700 µL of 0.9% sodium chloride (NaCl) at month 0, 1 and 4
Receives: Biological: NaCl

What is being measured

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

  1. Safety of 3 EN41-UGR7C administrations

    1. Safety assessed at any time from the first dose until 3 months after last administration by:Proportion of subjects developing Grade 3 or 4 adverse event

    Measured: Up to 3 months after the last administration

  2. Assessment of EN41-UGR7C immunogenicity

    Immunogenicity: to assess the EN41-UGR7C specific serum IgG responses measured by ELISA induced by the vaccine candidate up to 3 months after the final administration with a 3-fold increase from pre-administration baseline sample taken at visit 2, week 0.

    If no serum sample is available from this time point, serum taken at visit 1, screening, may be substituted.

    Measured: Up to 3 months after the final administration

Secondary outcomes (1)

  1. EN41-UGR7C specific ELISA IgA responses

    -To measure the EN41-UGR7C specific ELISA IgA responses in serum and EN41-UGR7C IgA and IgG responses in vaginal samples up to 3 months after the final administration

    Measured: Up to 3 months after the final administration

Timeline

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

  1. First posted9 Apr 2013 (estimated)
  2. Study startApr 2013
  3. Primary completionNov 2013
  4. Study completionFeb 2014

Resources

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
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01827397
Sponsor's protocol ID
EN41CT1.1.2
Status last verified
May 2014
First submitted
4 Apr 2013
Last updated
21 May 2014
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing EN41-UGR7C HIV vaccine and NaCl 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 14 inclusion and 26 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 3 EN41-UGR7C administrations (time frame: Up to 3 months after the last administration). 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 NCT01827397.

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.

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