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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Active Comparator | 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 |
|
| Group B | Experimental | 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 |
|
| Group C | Experimental | 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 |
|
| Group D | Experimental | 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 |
|
| Group E | Active Comparator | 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ad4-EnvCN54 | Biological | Live, replication-competent adenovirus 4 vector, engineered to express the envelope glycoprotein of HIV-1 isolate 97CN54 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 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 | At two weeks after the final immunisation |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | At two weeks post-final immunisation |
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Inclusion Criteria:
Men and women aged between 18 and 50 years on the day of screening
BMI 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 informed consent
At low risk of HIV infection and willing to remain so for the duration of the study defined as:
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 contraception, 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:
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 immunocompromised individual thought to be at clinical risk from Adenovirus infection
Clinically relevant abnormality on history or examination including:
Known hypersensitivity 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
Receipt of live attenuated vaccine within 60 days or other vaccine within 30 days of enrolment
Receipt of an experimental vaccines containing HIV 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 steroids (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 hepatitis B surface antigen, hepatitis C 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 contraception (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
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| Name | Affiliation | Role |
|---|---|---|
| David Lewis, MD | Imperial College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NIHR Imperial Clinical Research Facility | London | W12 0HS | United Kingdom |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 CN54gp140/MPLA: Recombinant glycoprotein of HIV-1 isolate 97CN54, with liposomal monophosphoryl lipid A adjuvant |
| FG001 | 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 Ad4-EnvCN54: Live, replication-competent adenovirus 4 vector, engineered to express the envelope glycoprotein of HIV-1 isolate 97CN54 CN54gp140/MPLA: Recombinant glycoprotein of HIV-1 isolate 97CN54, with liposomal monophosphoryl lipid A adjuvant |
| FG002 | 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 Ad4-EnvCN54: Live, replication-competent adenovirus 4 vector, engineered to express the envelope glycoprotein of HIV-1 isolate 97CN54 CN54gp140/MPLA: Recombinant glycoprotein of HIV-1 isolate 97CN54, with liposomal monophosphoryl lipid A adjuvant |
| FG003 | 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 Ad4-EnvCN54: Live, replication-competent adenovirus 4 vector, engineered to express the envelope glycoprotein of HIV-1 isolate 97CN54 CN54gp140/MPLA: Recombinant glycoprotein of HIV-1 isolate 97CN54, with liposomal monophosphoryl lipid A adjuvant |
| FG004 | 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 MVA-CN54: Live, non-replicating modified vaccinia Ankara vector, engineered to express the envelope glycoprotein of HIV-1 isolate 97CN54 CN54gp140/MPLA: Recombinant glycoprotein of HIV-1 isolate 97CN54, with liposomal monophosphoryl lipid A adjuvant |
| FG005 | 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 Ad4-EnvCN54: Live, replication-competent adenovirus 4 vector, engineered to express the envelope glycoprotein of HIV-1 isolate 97CN54 MVA-CN54: Live, non-replicating modified vaccinia Ankara vector, engineered to express the envelope glycoprotein of HIV-1 isolate 97CN54 CN54gp140/MPLA: Recombinant glycoprotein of HIV-1 isolate 97CN54, with liposomal monophosphoryl lipid A adjuvant |
| FG006 | 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 Ad4-EnvCN54: Live, replication-competent adenovirus 4 vector, engineered to express the envelope glycoprotein of HIV-1 isolate 97CN54 MVA-CN54: Live, non-replicating modified vaccinia Ankara vector, engineered to express the envelope glycoprotein of HIV-1 isolate 97CN54 CN54gp140/MPLA: Recombinant glycoprotein of HIV-1 isolate 97CN54, with liposomal monophosphoryl lipid A adjuvant |
| FG007 | 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 Ad4-EnvCN54: Live, replication-competent adenovirus 4 vector, engineered to express the envelope glycoprotein of HIV-1 isolate 97CN54 MVA-CN54: Live, non-replicating modified vaccinia Ankara vector, engineered to express the envelope glycoprotein of HIV-1 isolate 97CN54 CN54gp140/MPLA: Recombinant glycoprotein of HIV-1 isolate 97CN54, with liposomal monophosphoryl lipid A adjuvant |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Healthy male or female adults, 18 to 50 years of age, at low risk for HIV infection.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 CN54gp140/MPLA: Recombinant glycoprotein of HIV-1 isolate 97CN54, with liposomal monophosphoryl lipid A adjuvant |
| BG001 | Group B |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Count of Participants | Participants | At two weeks after the final immunisation |
|
12 months
All adverse events were recorded. Grades were defined as 1 (mild), 2 (moderate), 3 (severe) or 4 (life threatening).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 CN54gp140/MPLA: Recombinant glycoprotein of HIV-1 isolate 97CN54, with liposomal monophosphoryl lipid A adjuvant |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Depressive Disorder Triggering Overdose | Psychiatric disorders | MedDRA (19.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myalgia | General disorders | MedDRA (19.0) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Research Integrity Officer | Imperial College London | 020 7594 1872 | rgit@imperial.ac.uk |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 1, 2019 | Jul 25, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 20, 2021 | Jul 25, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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|
| Group F | Experimental | 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 |
|
| Group G | Experimental | 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 |
|
| Group H | Experimental | 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 |
|
| MVA-CN54 | Biological | Live, non-replicating modified vaccinia Ankara vector, engineered to express the envelope glycoprotein of HIV-1 isolate 97CN54 |
|
| CN54gp140/MPLA | Biological | Recombinant glycoprotein of HIV-1 isolate 97CN54, with liposomal monophosphoryl lipid A adjuvant |
|
|
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 Ad4-EnvCN54: Live, replication-competent adenovirus 4 vector, engineered to express the envelope glycoprotein of HIV-1 isolate 97CN54 CN54gp140/MPLA: Recombinant glycoprotein of HIV-1 isolate 97CN54, with liposomal monophosphoryl lipid A adjuvant |
| BG002 | 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 Ad4-EnvCN54: Live, replication-competent adenovirus 4 vector, engineered to express the envelope glycoprotein of HIV-1 isolate 97CN54 CN54gp140/MPLA: Recombinant glycoprotein of HIV-1 isolate 97CN54, with liposomal monophosphoryl lipid A adjuvant |
| BG003 | 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 Ad4-EnvCN54: Live, replication-competent adenovirus 4 vector, engineered to express the envelope glycoprotein of HIV-1 isolate 97CN54 CN54gp140/MPLA: Recombinant glycoprotein of HIV-1 isolate 97CN54, with liposomal monophosphoryl lipid A adjuvant |
| BG004 | 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 MVA-CN54: Live, non-replicating modified vaccinia Ankara vector, engineered to express the envelope glycoprotein of HIV-1 isolate 97CN54 CN54gp140/MPLA: Recombinant glycoprotein of HIV-1 isolate 97CN54, with liposomal monophosphoryl lipid A adjuvant |
| BG005 | 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 Ad4-EnvCN54: Live, replication-competent adenovirus 4 vector, engineered to express the envelope glycoprotein of HIV-1 isolate 97CN54 MVA-CN54: Live, non-replicating modified vaccinia Ankara vector, engineered to express the envelope glycoprotein of HIV-1 isolate 97CN54 CN54gp140/MPLA: Recombinant glycoprotein of HIV-1 isolate 97CN54, with liposomal monophosphoryl lipid A adjuvant |
| BG006 | 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 Ad4-EnvCN54: Live, replication-competent adenovirus 4 vector, engineered to express the envelope glycoprotein of HIV-1 isolate 97CN54 MVA-CN54: Live, non-replicating modified vaccinia Ankara vector, engineered to express the envelope glycoprotein of HIV-1 isolate 97CN54 CN54gp140/MPLA: Recombinant glycoprotein of HIV-1 isolate 97CN54, with liposomal monophosphoryl lipid A adjuvant |
| BG007 | 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 Ad4-EnvCN54: Live, replication-competent adenovirus 4 vector, engineered to express the envelope glycoprotein of HIV-1 isolate 97CN54 MVA-CN54: Live, non-replicating modified vaccinia Ankara vector, engineered to express the envelope glycoprotein of HIV-1 isolate 97CN54 CN54gp140/MPLA: Recombinant glycoprotein of HIV-1 isolate 97CN54, with liposomal monophosphoryl lipid A adjuvant |
| BG008 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Number of participants with CN54-gp140 IgG antibodies at time of vaccination | CN54-gp140 serum IgG antibodies were measured at baseline, before the participants received any vaccinations | Count of Participants | Participants |
|
| OG002 | 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 Ad4-EnvCN54: Live, replication-competent adenovirus 4 vector, engineered to express the envelope glycoprotein of HIV-1 isolate 97CN54 CN54gp140/MPLA: Recombinant glycoprotein of HIV-1 isolate 97CN54, with liposomal monophosphoryl lipid A adjuvant |
| OG003 | 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 Ad4-EnvCN54: Live, replication-competent adenovirus 4 vector, engineered to express the envelope glycoprotein of HIV-1 isolate 97CN54 CN54gp140/MPLA: Recombinant glycoprotein of HIV-1 isolate 97CN54, with liposomal monophosphoryl lipid A adjuvant |
| OG004 | 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 MVA-CN54: Live, non-replicating modified vaccinia Ankara vector, engineered to express the envelope glycoprotein of HIV-1 isolate 97CN54 CN54gp140/MPLA: Recombinant glycoprotein of HIV-1 isolate 97CN54, with liposomal monophosphoryl lipid A adjuvant |
| OG005 | 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 Ad4-EnvCN54: Live, replication-competent adenovirus 4 vector, engineered to express the envelope glycoprotein of HIV-1 isolate 97CN54 MVA-CN54: Live, non-replicating modified vaccinia Ankara vector, engineered to express the envelope glycoprotein of HIV-1 isolate 97CN54 CN54gp140/MPLA: Recombinant glycoprotein of HIV-1 isolate 97CN54, with liposomal monophosphoryl lipid A adjuvant |
| OG006 | 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 Ad4-EnvCN54: Live, replication-competent adenovirus 4 vector, engineered to express the envelope glycoprotein of HIV-1 isolate 97CN54 MVA-CN54: Live, non-replicating modified vaccinia Ankara vector, engineered to express the envelope glycoprotein of HIV-1 isolate 97CN54 CN54gp140/MPLA: Recombinant glycoprotein of HIV-1 isolate 97CN54, with liposomal monophosphoryl lipid A adjuvant |
| OG007 | 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 Ad4-EnvCN54: Live, replication-competent adenovirus 4 vector, engineered to express the envelope glycoprotein of HIV-1 isolate 97CN54 MVA-CN54: Live, non-replicating modified vaccinia Ankara vector, engineered to express the envelope glycoprotein of HIV-1 isolate 97CN54 CN54gp140/MPLA: Recombinant glycoprotein of HIV-1 isolate 97CN54, with liposomal monophosphoryl lipid A adjuvant |
|
|
| Primary | 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 | Posted | Count of Participants | Participants | Up to twenty-four weeks after the final immunisation |
|
|
|
| Primary | 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 | Serum from participants at two weeks after the final immunisation | Posted | Median | Inter-Quartile Range | ng/mL | At two weeks after the final immunisation |
|
|
|
| Secondary | 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 | Posted | Count of Participants | Participants | At two weeks post-final immunisation |
|
|
|
| 0 |
| 12 |
| 1 |
| 12 |
| 6 |
| 12 |
| EG001 | 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 Ad4-EnvCN54: Live, replication-competent adenovirus 4 vector, engineered to express the envelope glycoprotein of HIV-1 isolate 97CN54 CN54gp140/MPLA: Recombinant glycoprotein of HIV-1 isolate 97CN54, with liposomal monophosphoryl lipid A adjuvant | 0 | 6 | 0 | 6 | 3 | 6 |
| EG002 | 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 Ad4-EnvCN54: Live, replication-competent adenovirus 4 vector, engineered to express the envelope glycoprotein of HIV-1 isolate 97CN54 CN54gp140/MPLA: Recombinant glycoprotein of HIV-1 isolate 97CN54, with liposomal monophosphoryl lipid A adjuvant | 0 | 6 | 1 | 6 | 2 | 6 |
| EG003 | 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 Ad4-EnvCN54: Live, replication-competent adenovirus 4 vector, engineered to express the envelope glycoprotein of HIV-1 isolate 97CN54 CN54gp140/MPLA: Recombinant glycoprotein of HIV-1 isolate 97CN54, with liposomal monophosphoryl lipid A adjuvant | 0 | 12 | 0 | 12 | 9 | 12 |
| EG004 | 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 MVA-CN54: Live, non-replicating modified vaccinia Ankara vector, engineered to express the envelope glycoprotein of HIV-1 isolate 97CN54 CN54gp140/MPLA: Recombinant glycoprotein of HIV-1 isolate 97CN54, with liposomal monophosphoryl lipid A adjuvant | 0 | 6 | 0 | 6 | 3 | 6 |
| EG005 | 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 Ad4-EnvCN54: Live, replication-competent adenovirus 4 vector, engineered to express the envelope glycoprotein of HIV-1 isolate 97CN54 MVA-CN54: Live, non-replicating modified vaccinia Ankara vector, engineered to express the envelope glycoprotein of HIV-1 isolate 97CN54 CN54gp140/MPLA: Recombinant glycoprotein of HIV-1 isolate 97CN54, with liposomal monophosphoryl lipid A adjuvant | 0 | 6 | 1 | 6 | 3 | 6 |
| EG006 | 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 Ad4-EnvCN54: Live, replication-competent adenovirus 4 vector, engineered to express the envelope glycoprotein of HIV-1 isolate 97CN54 MVA-CN54: Live, non-replicating modified vaccinia Ankara vector, engineered to express the envelope glycoprotein of HIV-1 isolate 97CN54 CN54gp140/MPLA: Recombinant glycoprotein of HIV-1 isolate 97CN54, with liposomal monophosphoryl lipid A adjuvant | 0 | 6 | 0 | 6 | 3 | 6 |
| EG007 | 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 Ad4-EnvCN54: Live, replication-competent adenovirus 4 vector, engineered to express the envelope glycoprotein of HIV-1 isolate 97CN54 MVA-CN54: Live, non-replicating modified vaccinia Ankara vector, engineered to express the envelope glycoprotein of HIV-1 isolate 97CN54 CN54gp140/MPLA: Recombinant glycoprotein of HIV-1 isolate 97CN54, with liposomal monophosphoryl lipid A adjuvant | 0 | 6 | 3 | 6 | 5 | 6 |
| UTI on Kidney stones | Renal and urinary disorders | MedDRA (19.0) | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
|
| Blood loss anaemia | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment |
|
| Haematemesis secondary to Mallory Weiss | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Concussion | General disorders | MedDRA (19.0) | Systematic Assessment |
|
| Cellulitis on hand | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| Diverticulitis | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Tenderness left arm | Product Issues | MedDRA (19.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Anal haemorrhage | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Fungal skin infection | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| Dizziness | General disorders | MedDRA (19.0) | Systematic Assessment |
|
| Headache | General disorders | MedDRA (19.0) | Systematic Assessment |
|
| Right wrist synovialcyst surgical removal | Surgical and medical procedures | MedDRA (19.0) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (19.0) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Rhinorrhoea/nasopharyngitis/rhinitis/cold/upper respiratory tract infection | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Road traffic accident | General disorders | MedDRA (19.0) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| Chromaturia | Renal and urinary disorders | MedDRA (19.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Dysmenorrhea | Reproductive system and breast disorders | MedDRA (19.0) | Systematic Assessment |
|
| Sports injury | Social circumstances | MedDRA (19.0) | Systematic Assessment |
|
| Influenza like illness | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
|
| Lateral femoral nerve compression | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| Vomiting, vision blurred, headache and fatigue | General disorders | MedDRA (19.0) | Systematic Assessment |
|
| Hangover/Alcoholic Withdrawal Symptoms | Social circumstances | MedDRA (19.0) | Systematic Assessment |
|
| Thrombocytosis | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment |
|
| Gastroenteritis | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Mouth Ulceration | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Toothache | General disorders | MedDRA (19.0) | Systematic Assessment |
|
| Feverish | General disorders | MedDRA (19.0) | Systematic Assessment |
|
| Eye pruritis | Ear and labyrinth disorders | MedDRA (19.0) | Systematic Assessment |
|
| Dygeusia | General disorders | MedDRA (19.0) | Systematic Assessment |
|
| Urinary tract infection | Renal and urinary disorders | MedDRA (19.0) | Systematic Assessment |
|
| Testicular pain | Reproductive system and breast disorders | MedDRA (19.0) | Systematic Assessment |
|
| Conjunctivitis | Eye disorders | MedDRA (19.0) | Systematic Assessment |
|
| Oropharyngeal discomfort | General disorders | MedDRA (19.0) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (19.0) | Systematic Assessment |
|
| Biceps tendon tenderness | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| Pruritis | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| Cystitis | Renal and urinary disorders | MedDRA (19.0) | Systematic Assessment |
|
| shoulder/clavicle region tenderness | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| Panic attack | Psychiatric disorders | MedDRA (19.0) | Systematic Assessment |
|
| lower respiratory tract infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
|
| Vulvovaginal pruritus | Reproductive system and breast disorders | MedDRA (19.0) | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| Threadworm infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |