CompletedNCT03408262Ad4HIVUpdated Oct 16, 2024Results posted

Clinical Trial of HIV Vaccine Combinations in Healthy Men and Women

A Phase 1 interventional study of Ad4-EnvCN54 and MVA-CN54 in Human Immunodeficiency Virus, sponsored by Imperial College London. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-16.

Primary conditionAcquired Immunodeficiency Syndrome(the registry's first term)UnverifiedIs this wrong?The registry often attaches Acquired Immunodeficiency Syndrome to studies about something else, and this study's title and listed conditions do not name it. No better condition is named, so the registry's term is kept.

Sponsored by Imperial College London · Phase 1, Interventional, and Prevention

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Phase: Phase 1
Study type: Interventional
Enrollment: 68
Allocation: Randomized
Ages: 18 Years to 50 Years
Sex: All

Study summary

A Phase I Single-Blind randomised trial investigating immunisation strategies using Ad4-EnvCN54, MVA-CN54 and CN54gp140/MPLA combinations in order to maximise antibody responses to Human Immunodeficiency Virus

Read the detailed description

This is a randomised two-part Phase I study which will explore the impact of different boosting options (MVA-CN54 and recombinant CN54gp140 protein) for oral Adenovirus serotype 4 vector prime expressing HIV-1 CN54 envelope (Ad4-EnvCN54) designed to optimize systemic and mucosal antibody responses.

Part 1 is exploratory and designed to select conditions capable of promoting enhanced systemic and mucosal B cell responses in a limited number of participants.

Part 2 is dependent upon Part 1 and is designed to study groups selected on performance in part 1 in an expanded number of subjects. Data from both stages will be combined for safety and immunological analyses.

Conditions studied

Human Immunodeficiency Virus

Browse trials for

Acquired Immunodeficiency Syndrome 3,037Registry's first term · unverified

In context

Acquired Immunodeficiency Syndrome Unverified

3,037 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 307 are open to participants now.

This study's enrollment of 68 is below the median of 96 across 2,252 interventional studies indexed under Acquired Immunodeficiency Syndrome.

Browse Acquired Immunodeficiency Syndrome studies →

Lead sponsor

Imperial College London is the lead sponsor of 843 studies on the registry; 180 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.

Browse Imperial College London studies →

Compared within Acquired Immunodeficiency Syndrome, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →

Who can participate

Ages eligible: 18 Years to 50 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Men and women aged between 18 and 50 years on the day of screening
between 18-30
Seronegative for Adenovirus 4 serum neutralising antibodies
Available for follow-up for the duration of the study
Willing and able to give written
At low risk of 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
- no high risk partner (e.g. injecting drug use, HIV positive partner) either currently or within the past six months
- no unprotected anal or vaginal intercourse in the last six months, outside a relationship with a regular partner known to be HIV negative
Willing to undergo HIV testing
Willing to undergo a STI screen for chlamydia, gonorrhoea and syphilis
Must agree to require male sexual partner to use condoms, from at least 14 days before the first vaccination until at least 4 months after the last
If heterosexually active female capable of becoming pregnant, must (in addition to requiring male partner to use condoms) agree to use hormonal , or to complete abstinence, from at least 30 days before the first vaccination until at least 4 months after the last. [Note: Acceptable hormonal contraception is combined (estrogen and progestogen containing) or progestogen-only hormonal contraception associated with inhibition of ovulation. Complete abstinence can be used, when in line with the preferred and usual lifestyle of the subject. Periodic abstinence (calendar, symptothermal, post-ovulation methods), withdrawal (coitus interruptus), spermicides only, lactational amenorrhoea method, and IUD/IUS are not acceptable methods of contraception.]
If sexually active male, must agree to use condoms from the day of first vaccination until at least 4 months after the last. [Note: Additional use of an effective method of contraception is recommended for any non-pregnant female partner over the same period.]
Agree to abstain from donating blood, eggs or sperm from the day of first vaccination until at least 3 months after the end of their participation in the trial
Registered with a GP for at least the past month
Entered and clearance obtained from The Overvolunteering Prevention System (TOPS) database

Exclusion criteria

Exclusion Criteria:

Are pregnant or breast feeding, or living with anyone under the age of 5 years old or over 75 years old
Have close contact with an individual thought to be at clinical risk from Adenovirus infection
abnormality on history or examination including:
1. Liver disease with inadequate hepatic function
2. Any skin condition which may interfere with the trial assessment of the injection sites
3. Haematological, metabolic, gastrointestinal or cardio-pulmonary disorders
4. Uncontrolled infection; disease, immunodeficiency
Known to any component of the vaccine formulations used in this trial, or have severe or multiple allergies to drugs or pharmaceutical agents
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 arm, not resolving within 72 hours
- General: fever ≥39.5oC within 48 hours; anaphylaxis; bronchospasm; laryngeal oedema; collapse; convulsions or encephalopathy within 72 hours
Receipt of within 60 days or other vaccine within 30 days of enrolment
Receipt of an experimental vaccines containing antigens, Ad4 and MVA-C products at any time in the past
Receipt of blood products or immunoglobin within 4 months of screening, or drugs that suppress the immune system, such as (including inhaled steroids, excluding topical steroids unless applied to the upper arm), in the preceding 3 months
Participating in another trial of a medicinal product, completed less than 30 days prior to enrolment
HIV 1 or 2 positive or indeterminate on screening
Positive for antibodies to surface antigen, antibody or serology indicating active syphilis requiring treatment
Clinically significant positive reaction in antinuclear antibody screen or clinically significant immunoglobulin (IgA, IgG or IgM) values
Grade 1 or above clinically significant routine laboratory parameters
Unable to read and/or speak English to a fluency level adequate for the full comprehension of procedures required in participation and consent
Women with a history of toxic shock syndrome
Women using an intrauterine device for (as incompatible with softcup sampling)
Any other significant disease, disorder or finding which may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to participate in the study or impair interpretation of the study data
Unlikely to comply with protocol

Terms in these criteria, in plain language(12)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Live vaccines

Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

Study design

Phase: Phase 1
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Single (Participant)
Enrollment: 68 participants (actual)

Study arms

Active comparator
Group A
Month 0: oral placebo Month 3: oral placebo + I.M. CN54gp140/MPLA + I.M. placebo Month 6: oral placebo + I.M. CN54gp140/MPLA + I.M. placebo
Biological: CN54gp140/MPLA
Experimental
Group B
Month 0: Ad4-EnvCN54 Month 3: oral placebo + I.M. CN54gp140/MPLA + I.M. placebo Month 6: oral placebo + I.M. CN54gp140/MPLA + I.M. placebo
Biological: Ad4-EnvCN54 · Biological: CN54gp140/MPLA
Experimental
Group C
Month 0: Ad4-EnvCN54 Month 3: Ad4-EnvCN54 + I.M. CN54gp140/MPLA + I.M. placebo Month 6: oral placebo + I.M. CN54gp140/MPLA + I.M. placebo
Biological: Ad4-EnvCN54 · Biological: CN54gp140/MPLA
Experimental
Group D
Month 0: Ad4-EnvCN54 Month 3: Ad4-EnvCN54 + I.M. CN54gp140/MPLA + I.M. placebo Month 6: Ad4-EnvCN54 + I.M. CN54gp140/MPLA + I.M. placebo
Biological: Ad4-EnvCN54 · Biological: CN54gp140/MPLA
Active comparator
Group E
Month 0: oral placebo Month 3: oral placebo + I.M. CN54gp140/MPLA + I.M. MVA-CN54 Month 6: oral placebo + I.M. CN54gp140/MPLA + I.M. MVA-CN54
Biological: MVA-CN54 · Biological: CN54gp140/MPLA
Experimental
Group F
Month 0: Ad4-EnvCN54 Month 3: oral placebo + I.M. CN54gp140/MPLA + I.M. MVA-CN54 Month 6: oral placebo + I.M. CN54gp140/MPLA + I.M. MVA-CN54
Biological: Ad4-EnvCN54 · Biological: MVA-CN54 · Biological: CN54gp140/MPLA
Experimental
Group G
Month 0: Ad4-EnvCN54 Month 3: Ad4-EnvCN54 + I.M. CN54gp140/MPLA + I.M. MVA-CN54 Month 6: oral placebo + I.M. CN54gp140/MPLA + I.M. MVA-CN54
Biological: Ad4-EnvCN54 · Biological: MVA-CN54 · Biological: CN54gp140/MPLA
Experimental
Group H
Month 0: Ad4-EnvCN54 Month 3: Ad4-EnvCN54 + I.M. CN54gp140/MPLA + I.M. MVA-CN54 Month 6: Ad4-EnvCN54 + I.M. CN54gp140/MPLA + I.M. MVA-CN54
Biological: Ad4-EnvCN54 · Biological: MVA-CN54 · Biological: CN54gp140/MPLA

Interventions

BiologicalAd4-EnvCN54
Live, replication-competent adenovirus 4 vector, engineered to express the envelope glycoprotein of HIV-1 isolate 97CN54
BiologicalMVA-CN54
Live, non-replicating modified vaccinia Ankara vector, engineered to express the envelope glycoprotein of HIV-1 isolate 97CN54
BiologicalCN54gp140/MPLA
Recombinant glycoprotein of HIV-1 isolate 97CN54, with liposomal monophosphoryl lipid A adjuvant
Also known as: CN54-M

What researchers measure

Primary outcomes

Number of Participants With Mucosal Binding IgG Antibodies to HIV CN54gp140 Antigen
Number of participants with mucosal (semen, nasal, vaginal or rectal) binding IgG antibodies to HIV CN54gp140 antigen, as determined by ELISA
Time frame: At two weeks after the final immunisation
Number of Participants With Severe or Greater (Grades 3-4) Adverse Reactions During the Study
Number of Participants With Severe or Greater (Grades 3-4) Adverse Reactions up to twenty-four weeks after the final immunisation
Time frame: Up to twenty-four weeks after the final immunisation
Median Concentration of CN54-gp140 Specific IgG Binding Antibodies
Median concentration of CN54-gp140 specific IgG binding antibodies, as measured by ELISA. Concentration is in ng/mL
Time frame: At two weeks after the final immunisation

Secondary outcomes

Number of Participants With Detectable Serum Binding Antibodies to HIV CN54gp140 Antigen
Number of participants with detectable serum binding antibodies to HIV CN54gp140 antigen, as measured by IgG binding ELISA
Time frame: At two weeks post-final immunisation

Results

Posted Oct 16, 2024

Participant flow

Participant flow — Overall Study
Milestone	Group A	Group B	Group C	Group D	Group E	Group F	Group G	Group H
Started	15	6	6	13	6	6	9	7
Completed	11	6	6	12	6	6	6	6
Not completed	4	0	0	1	0	0	3	1

Outcome measures

PrimaryNumber of Participants With Mucosal Binding IgG Antibodies to HIV CN54gp140 Antigen

Number of participants with mucosal (semen, nasal, vaginal or rectal) binding IgG antibodies to HIV CN54gp140 antigen, as determined by ELISA

Time frame:: At two weeks after the final immunisation
Reported as:: Count of participants · Participants

Number of Participants With Mucosal Binding IgG Antibodies to HIV CN54gp140 Antigen
Participants	Group A	Group B	Group C	Group D	Group E	Group F	Group G	Group H
Number of Participants With Mucosal Binding IgG Antibodies to HIV CN54gp140 Antigen	0	3	1	6	0	1	2	1

PrimaryNumber of Participants With Severe or Greater (Grades 3-4) Adverse Reactions During the Study

Number of Participants With Severe or Greater (Grades 3-4) Adverse Reactions up to twenty-four weeks after the final immunisation

Time frame:: Up to twenty-four weeks after the final immunisation
Reported as:: Count of participants · Participants

Number of Participants With Severe or Greater (Grades 3-4) Adverse Reactions During the Study
Participants	Group A	Group B	Group C	Group D	Group E	Group F	Group G	Group H
Number of Participants With Severe or Greater (Grades 3-4) Adverse Reactions During the Study	1	0	1	0	0	1	0	3

PrimaryMedian Concentration of CN54-gp140 Specific IgG Binding Antibodies

Median concentration of CN54-gp140 specific IgG binding antibodies, as measured by ELISA. Concentration is in ng/mL

Time frame:: At two weeks after the final immunisation
Reported as:: Median · ng/mL

Median Concentration of CN54-gp140 Specific IgG Binding Antibodies
ng/mL	Group A	Group B	Group C	Group D	Group E	Group F	Group G	Group H
Median Concentration of CN54-gp140 Specific IgG Binding Antibodies	464 (23 to 1521)	14141 (3971 to 18348)	8992 (3798 to 79435)	11367 (398 to 26149)	6280 (1102 to 15044)	9639 (3250 to 14282)	20512 (10583 to 36552)	9041 (4735 to 21023)

SecondaryNumber of Participants With Detectable Serum Binding Antibodies to HIV CN54gp140 Antigen

Number of participants with detectable serum binding antibodies to HIV CN54gp140 antigen, as measured by IgG binding ELISA

Time frame:: At two weeks post-final immunisation
Reported as:: Count of participants · Participants

Number of Participants With Detectable Serum Binding Antibodies to HIV CN54gp140 Antigen
Participants	Group A	Group B	Group C	Group D	Group E	Group F	Group G	Group H
Number of Participants With Detectable Serum Binding Antibodies to HIV CN54gp140 Antigen	7	6	5	11	6	6	6	6

Adverse events

Collected over 12 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Group A	0/12 (0%)	1/12 (8.3%)	6/12 (50%)
Group B	0/6 (0%)	0/6 (0%)	3/6 (50%)
Group C	0/6 (0%)	1/6 (16.7%)	2/6 (33.3%)
Group D	0/12 (0%)	0/12 (0%)	9/12 (75%)
Group E	0/6 (0%)	0/6 (0%)	3/6 (50%)
Group F	0/6 (0%)	1/6 (16.7%)	3/6 (50%)
Group G	0/6 (0%)	0/6 (0%)	3/6 (50%)
Group H	0/6 (0%)	3/6 (50%)	5/6 (83.3%)

Most frequent serious events

Most frequent serious events
Event	Group A	Group B	Group C	Group D	Group E	Group F	Group G	Group H
UTI on Kidney stonesRenal and urinary disorders	0/12	0/6	0/6	0/12	0/6	0/6	0/6	1/6
PalpitationsCardiac disorders	0/12	0/6	0/6	0/12	0/6	0/6	0/6	1/6
Blood loss anaemiaBlood and lymphatic system disorders	0/12	0/6	0/6	0/12	0/6	0/6	0/6	1/6
Haematemesis secondary to Mallory WeissGastrointestinal disorders	0/12	0/6	0/6	0/12	0/6	0/6	0/6	1/6
ConcussionGeneral disorders	0/12	0/6	0/6	0/12	0/6	0/6	0/6	1/6
Cellulitis on handSkin and subcutaneous tissue disorders	0/12	0/6	1/6	0/12	0/6	0/6	0/6	0/6
DiverticulitisGastrointestinal disorders	0/12	0/6	0/6	0/12	0/6	1/6	0/6	0/6
Depressive Disorder Triggering OverdosePsychiatric disorders	1/12	0/6	0/6	0/12	0/6	0/6	0/6	0/6

Most frequent other events

Showing 10 of 44

Most frequent other events
Event	Group A	Group B	Group C	Group D	Group E	Group F	Group G	Group H
Rhinorrhoea/nasopharyngitis/rhinitis/cold/upper respiratory tract infectionRespiratory, thoracic and mediastinal disorders	4/12	2/6	2/6	4/12	1/6	1/6	3/6	1/6
VomitingGastrointestinal disorders	0/12	0/6	0/6	0/12	0/6	0/6	0/6	2/6
MyalgiaGeneral disorders	0/12	1/6	0/6	0/12	0/6	0/6	0/6	0/6
Tenderness left armProduct Issues	0/12	1/6	0/6	0/12	0/6	0/6	0/6	0/6
CoughRespiratory, thoracic and mediastinal disorders	0/12	1/6	0/6	0/12	0/6	0/6	0/6	0/6
Anal haemorrhageGastrointestinal disorders	0/12	0/6	1/6	0/12	0/6	0/6	0/6	0/6
DizzinessGeneral disorders	0/12	0/6	1/6	0/12	0/6	1/6	0/6	1/6
HeadacheGeneral disorders	0/12	1/6	1/6	1/12	1/6	0/6	1/6	0/6
Right wrist synovialcyst surgical removalSurgical and medical procedures	0/12	0/6	1/6	0/12	0/6	0/6	0/6	0/6
PyrexiaGeneral disorders	0/12	0/6	1/6	0/12	0/6	0/6	0/6	0/6

Baseline characteristics

Healthy male or female adults, 18 to 50 years of age, at low risk for HIV infection.

Age, Categorical
Age, Categorical(Participants)	Group A	Group B	Group C	Group D	Group E	Group F	Group G	Group H	Total
<=18 years	0	0	0	0	0	0	0	0	0
Between 18 and 65 years	15	6	6	13	6	6	9	7	68
>=65 years	0	0	0	0	0	0	0	0	0

Sex: Female, Male
Sex: Female, Male(Participants)	Group A	Group B	Group C	Group D	Group E	Group F	Group G	Group H	Total
Female	7	2	3	6	2	2	4	3	29
Male	8	4	3	7	4	4	5	4	39

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	Group A	Group B	Group C	Group D	Group E	Group F	Group G	Group H	Total
White British	7	3	3	3	2	5	4	1	28
White Irish	0	0	0	0	0	0	0	0	0
Any other white background	5	0	0	3	4	0	2	3	17
Indian	1	1	0	1	0	1	0	0	4
Pakistani	0	0	0	1	0	0	0	0	1
Bangladeshi	0	0	0	0	0	0	0	0	0
Any other Asian background	0	1	0	2	0	0	1	2	6
Mixed White and Black Caribbean	0	0	0	1	0	0	0	0	1
Mixed White and Black African	1	0	0	0	0	0	0	0	1
Mixed White and Asian	0	0	0	0	0	0	0	0	0
Any other Mixed background	0	0	0	1	0	0	0	1	2
Black Caribbean	1	0	1	0	0	0	1	0	3
Black African	0	1	2	0	0	0	1	0	4
Any other Black background	0	0	0	1	0	0	0	0	1

Region of Enrollment
Region of Enrollment(participants)	Group A	Group B	Group C	Group D	Group E	Group F	Group G	Group H	Total
United Kingdom	15	6	6	13	6	6	9	7	68

Number of participants with CN54-gp140 IgG antibodies at time of vaccination
Number of participants with CN54-gp140 IgG antibodies at time of vaccination(Participants)	Group A	Group B	Group C	Group D	Group E	Group F	Group G	Group H	Total
Count of participants	0	0	0	0	0	0	0	0	0

Study locations

1 site

NIHR Imperial Clinical Research Facility
London, W12 0HS, United Kingdom

References and documents

Study documents

Study protocol ↗ · Nov 1, 2019
Statistical analysis plan ↗ · Jul 20, 2021

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Oct 2017 to primary completion in Feb 2020, 28 months.

Results were first posted in Oct 2024, 4 years 8 months after primary completion.

Of 63 non-industry phase 1 interventional studies under Acquired Immunodeficiency Syndrome, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 39. This study's 28 months is above that.

Counting every sponsor, half of 139 studies reached it within 14 months; a quarter within 4 and three quarters within 28.

How these figures are worked out, and which studies are left out of them.

Registered: Jan 5, 2018
First posted: Jan 23, 2018
StartActual: Oct 6, 2017
Primary completionActual: Feb 10, 2020
CompletionActual: Feb 10, 2020
Results first posted: Oct 16, 2024
Last update: Oct 16, 2024

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Oct 16, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03408262
Lead sponsor: Imperial College London
Responsible party: Sponsor
First posted: Jan 23, 2018
Start date: Oct 6, 2017
Primary completion: Feb 10, 2020
Completion: Feb 10, 2020
Results posted: Oct 16, 2024
Last update: Oct 16, 2024

Study contacts

David Lewis, MD

principal investigator · Imperial College London

Oversight

Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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