AzTrials
AzTrials

HIV InfectionsPhase 1NCT04041674

Evaluating the Safety and Immunogenicity of a Prime-boost Vaccine Regimen of GEO-D02 DNA and MVA/HIV62B With and Without B63521^11 gp120 and IHV01 gp120 Env Proteins in Healthy, HIV-uninfected Adult Participants

A Phase 1 study testing GEO-D02 DNA, MVA/HIV62B Vaccine and B63521^11 gp120 in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID).

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The purpose of this study is to evaluate the safety and immunogenicity of a prime-boost vaccine regimen of GEO-D02 DNA and MVA/HIV62B with and without B63521^11 gp120 and IHV01 gp120 Env proteins in healthy, HIV-uninfected adult participants. Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
HIV Infections
What is being tested?
GEO-D02 DNA, MVA/HIV62B Vaccine and B63521^11 gp120
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
No sites listed yet
Study dates
1 Mar 2022to 31 May 2023
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 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • General and Demographic Criteria
  • Age of 18 to 50 years
  • Access to a participating HVTN Clinical Research Site (CRS) and willingness to be followed for the planned duration of the study
  • Ability and willingness to provide informed consent
  • Assessment of understanding: volunteer demonstrates understanding of this study; completes a questionnaire prior to first vaccination with verbal demonstration of understanding of all questionnaire items answered incorrectly
  • Willing to be contacted after completion of scheduled clinic visits for a total of 2 years following initial study injection
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  • Agrees not to enroll in another study of an investigational research agent while in this study
  • Good general health as shown by medical history, physical exam, and screening laboratory tests
  • HIV-Related Criteria:
  • Willingness to receive HIV test results
  • Willingness to discuss HIV infection risks and amenable to HIV risk reduction counseling
  • Assessed by the clinic staff as being at "low risk" for HIV infection and committed to maintaining behavior consistent with low risk of HIV exposure through the last required protocol clinic visit (see the study protocol).
  • Laboratory Inclusion Values
  • Hemogram/Complete blood count (CBC)
  • Hemoglobin greater than or equal to 11.0 g/dL for volunteers who were assigned female sex at birth, greater than or equal to 13.0 g/dL for volunteers who were assigned male sex at birth. For transgender participants who have been on hormone therapy for more than 6 consecutive months, determine hemoglobin eligibility based on the gender with which they identify (ie, a transgender female who has been on hormone therapy for more than 6 consecutive months should be assessed for eligibility using the hemoglobin parameters for persons assigned female sex at birth).
  • White blood cell count equal to 2,500 to 12,000 cells/mm^3 with normal differential, or differential approved by Investigator of Record (IoR) as not clinically significant
  • Total lymphocyte count greater than or equal to 650 cells/mm^3 with normal differential, or differential approved by IoR as not clinically significant
  • Remaining differential either within institutional normal range or with site physician approval
  • Platelets equal to 125,000 to 550,000 cells/mm^3
  • Chemistry
  • Chemistry panel: alanine aminotransferase (ALT) less than 1.25 times the institutional upper limit of normal; creatinine less than or equal to 1.1 times the institutional upper limits of normal.
  • HIV Status
  • Negative HIV-1 and -2 blood test: US volunteers must have a negative U.S. Food and Drug Administration (FDA)-approved enzyme immunoassay (EIA).
  • Urine
  • Normal urine:
  • Negative or trace urine protein, and
  • Negative, trace, or 1+ blood urine hemoglobin (if +1 hemoglobin is present on dipstick, a microscopic urinalysis with red blood cells levels within institutional normal range).
  • Reproductive Status
  • Volunteers who were assigned female sex at birth: negative serum or urine beta human chorionic gonadotropin (β-HCG) pregnancy test at screening (ie, prior to randomization) and prior to study product administration on the day of study product administration. Persons who are NOT of reproductive potential due to having undergone hysterectomy or bilateral oophorectomy (verified by medical records), are not required to undergo pregnancy testing.
  • Reproductive status: A volunteer who was assigned female sex at birth:
  • Must agree to consistently use effective contraception (see the study protocol) for sexual activity that could lead to pregnancy from at least 21 days prior to enrollment until 3 months after the final study vaccination. Effective contraception is defined as using the following methods:
  • Condoms (male or female) with or without a spermicide,
  • Diaphragm or cervical cap with spermicide,
  • Intrauterine device (IUD),
  • Hormonal contraception,
  • Tubal ligation, or
  • Any other contraceptive method approved by the HVTN 132 Protocol Safety Review Team (PSRT)
  • Successful vasectomy in any partner assigned male sex at birth (considered successful if a volunteer reports that a male partner has [1] documentation of azoospermia by microscopy, or [2] a vasectomy more than 2 years ago with no resultant pregnancy despite sexual activity postvasectomy);
  • Or not be of reproductive potential, such as having reached menopause (no menses for 1 year) or having undergone hysterectomy, or bilateral oophorectomy;
  • Or be sexually abstinent.
  • Volunteers who were assigned female sex at birth must also agree not to seek pregnancy through alternative methods, such as artificial insemination or in vitro fertilization until after the last required protocol clinic visit.

Who cannot join

  • Blood products received within 120 days before first vaccination.
  • Investigational research agents received within 30 days before first vaccination.
  • Body mass index (BMI) greater than or equal to 40.
  • Volunteer has 2 or more of the following cardiac risk factors:
  • Participant report of history of elevated blood cholesterol defined as fasting low-density lipoprotein (LDL) greater than 160 mg/dL;
  • First degree relative (eg, mother, father, brother, or sister) who had coronary artery disease before the age of 50 years;
Show all 54Show fewer
  • Current smoker; or
  • BMI greater than or equal to 35.
  • Intent to participate in another study of an investigational research agent or any other study that requires non-HVTN HIV antibody testing during the planned duration of the HVTN 132 study.
  • Pregnant or breastfeeding.
  • Active duty and reserve US military personnel.
  • Vaccines and other Injections
  • Smallpox vaccine received within the last 5 years.
  • HIV vaccine(s) received in a prior HIV vaccine trial. For volunteers who have received control/placebo in an HIV vaccine trial, the HVTN 132 PSRT will determine eligibility on a case-by-case basis.
  • Non-HIV experimental vaccine(s) received within the last 1 year in a prior vaccine trial. Exceptions may be made by the HVTN 132 PSRT for vaccines that have subsequently undergone licensure by the FDA or by the national regulatory authority where the volunteer is enrolling. For volunteers who have received control/placebo in an experimental vaccine trial, the HVTN 132 PSRT will determine eligibility on a case-by-case basis. For volunteers who have received an experimental vaccine(s) greater than 1 year ago, eligibility for enrollment will be determined by the HVTN 132 PSRT on a case-by-case basis.
  • Live attenuated vaccines received within 30 days before first study injection or scheduled within 14 days after the first study injection (eg, measles, mumps, and rubella [MMR]; oral polio vaccine [OPV]; varicella; yellow fever; live attenuated influenza vaccine.)
  • Any vaccines that are not live attenuated vaccines and were received within 14 days prior to first vaccination (eg, tetanus, pneumococcal, Hepatitis A or B.)
  • Allergy treatment with antigen injections within 30 days before first vaccination or that are scheduled within 14 days after first vaccination.
  • Immune System
  • Immunosuppressive medications received within 168 days before first vaccination (Not exclusionary: [1] corticosteroid nasal spray; [2] inhaled corticosteroids; [3] topical corticosteroids for mild, uncomplicated dermatologic condition; or [4] a single course of oral/parenteral prednisone or equivalent at doses less than or equal to 60 mg/day and length of therapy less than 11 days with completion at least 30 days prior to enrollment.)
  • Serious adverse reactions to vaccines or to vaccine components such as mannitol, aluminum hydroxide, and egg products, including history of anaphylaxis and related symptoms such as hives, respiratory difficulty, angioedema, and/or abdominal pain. (Not excluded from participation: a volunteer who had a non-anaphylactic adverse reaction to pertussis vaccine as a child.)
  • Immunoglobulin received within 60 days before first vaccination.
  • Autoimmune disease, current or history (Not exclusionary: mild, well-controlled psoriasis.)
  • Immunodeficiency.
  • Cardiac
  • History of myocarditis, pericarditis, cardiomyopathy, congestive heart failure with permanent sequelae, clinically significant arrhythmia (including any arrhythmia requiring medication, treatment, or clinical follow-up.)
  • Electrocardiography (ECG) with clinically significant findings, or features that would interfere with the assessment of myo/pericarditis, as determined by a contract ECG Lab or cardiologist, including any of the following: (1) conduction disturbance (complete left or complete right bundle branch block or nonspecific intraventricular conduction disturbance with QRS greater than or equal to 120 ms, PR interval greater than or equal to 220ms, any second or third degree atrioventricular (AV) block, or QTc prolongation (greater than 450ms)); (2) repolarization (ST segment or T wave) abnormality that will interfere with the assessment of myo/pericarditis; (3) significant atrial or ventricular arrhythmia; (4) frequent atrial or ventricular ectopy (eg, frequent premature atrial contractions, 2 premature ventricular contractions in a row); (5) ST elevation consistent with ischemia; (6) evidence of past or evolving myocardial infarction.
  • Clinically significant medical conditions
  • Clinically significant medical condition, physical examination findings, clinically significant abnormal laboratory results, or past medical history with clinically significant implications for current health. A clinically significant condition or process includes but is not limited to:
  • A process that would affect the immune response,
  • A process that would require medication that affects the immune response,
  • Any contraindication to repeated injections or blood draws,
  • A condition that requires active medical intervention or monitoring to avert grave danger to the volunteer's health or well-being during the study period,
  • A condition or process for which signs or symptoms could be confused with reactions to vaccine, or
  • Any condition specifically listed among the exclusion criteria below.
  • Any medical, psychiatric, occupational, or other condition that, in the judgment of the investigator, would interfere with, or serve as a contraindication to, protocol adherence, assessment of safety or reactogenicity, or a volunteer's ability to give informed consent.
  • Psychiatric condition that 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.
  • Current anti-tuberculosis (TB) prophylaxis or therapy.
  • Asthma other than mild or moderate, well-controlled asthma. (Symptoms of asthma severity as defined in the most recent National Asthma Education and Prevention Program (NAEPP) Expert Panel report.) Exclude a volunteer who:
  • Uses a short-acting rescue inhaler (typically a beta 2 agonist) daily, or
  • Uses high dose inhaled corticosteroids, or
  • In the past year has had either of the following:
  • Greater than 1 exacerbation of symptoms treated with oral/parenteral corticosteroids;
  • Needed emergency care, urgent care, hospitalization, or intubation for asthma.
  • Diabetes mellitus type 1 or type 2 (Not exclusionary: type 2 cases controlled with diet alone or a history of isolated gestational diabetes.)
  • Thyroidectomy, or thyroid disease requiring medication during the last 12 months. (Not exclusionary: well-controlled non-autoimmune thyroid disease.)
  • Hypertension:
  • If a person has been found to have elevated blood pressure or hypertension during screening or previously, exclude for blood pressure that is not well controlled. Well-controlled blood pressure is defined in this protocol as consistently less than or equal to 140 mm Hg systolic and less than or equal to 90 mm Hg diastolic, with or without medication, with only isolated, brief instances of higher readings, which must be less than or equal to 150 mm Hg systolic and less than or equal to 100 mm Hg diastolic. For these volunteers, blood pressure must be less than or equal to 140 mm Hg systolic and less than or equal to 90 mm Hg diastolic at enrollment.
  • If a person has NOT been found to have elevated blood pressure or hypertension during screening or previously, exclude for systolic blood pressure greater than or equal to 150 mm Hg at enrollment or diastolic blood pressure greater than or equal to 100 mm Hg at enrollment.
  • Bleeding disorder (eg, factor deficiency, coagulopathy, or platelet disorder requiring special precautions.)
  • Malignancy (Not excluded from participation: Volunteer who has had malignancy excised surgically and who, in the investigator's estimation, has a reasonable assurance of sustained cure, or who is unlikely to experience recurrence of malignancy during the period of the study.)
  • Seizure disorder: History of seizure(s) within past three years. Also exclude if volunteer has used medications in order to prevent or treat seizure(s) at any time within the past 3 years.
  • Asplenia: any condition resulting in the absence of a functional spleen.
  • History of generalized urticaria, angioedema, or anaphylaxis. (Not exclusionary: angioedema or anaphylaxis to a known trigger with at least 5 years since last reaction to demonstrate satisfactory avoidance of trigger.)

About this study

Official title: A Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of a Prime-boost Vaccine Regimen of GEO-D02 DNA and MVA/HIV62B With and Without B63521^11 gp120 and IHV01 gp120 Env Proteins in Healthy, HIV-uninfected Adult Participants *Imatinib Mesylate Per Oral as a Clinical Therapeutic for TB

The purpose of this study is to evaluate the safety and immunogenicity of a prime-boost vaccine regimen of GEO-D02 DNA and MVA/HIV62B with and without B63521^11 gp120 and IHV01 gp120 Env proteins in healthy, HIV-uninfected adult participants.

Read the detailed description

This study will evaluate the safety and immunogenicity of a prime-boost vaccine regimen of GEO-D02 DNA and MVA/HIV62B with and without B63521^11 gp120 and IHV01 gp120 Env proteins in healthy, HIV-uninfected adult participants.

Participants will be randomly assigned to one of five groups. Participants in all five groups will receive GEO-D02 DNA by intramuscular (IM) injection at Months 0 and 2. Then, at Months 4, 6, and 10, participants will receive three additional injections according to their assigned group:

  • Group 1: MVA/HIV62B, placebo for B63521^11 gp120, and placebo for IHV01, all by IM injection
  • Group 2: MVA/HIV62B by IM injection and placebo for B63521^11 gp120 and for IHV01, both by subcutaneous (SC) injection
  • Group 3: MVA/HIV62B, B63521^11 gp120, and IHV01, all by IM injection
  • Group 4: MVA/HIV62B, placebo for B63521^11 gp120, and IHV01, all by IM injection
  • Group 5: MVA/HIV62B by IM injection and IHV01 and B63521^11 gp120, both by SC injection

Participants will attend several study visits through Month 16. Visits may include physical examinations, blood and urine collection, electrocardiogram, HIV testing, risk reduction counseling, and questionnaires. Study staff will contact participants at Month 24 for follow-up health monitoring.

Conditions
HIV Infections
Being tested
GEO-D02 DNA, MVA/HIV62B Vaccine, B63521^11 gp120, IHV01 Protein, Protein Placebo
Medical subject headings
HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GEO-D02 DNABiological

    Administered by IM injection into the vastus lateralis

  • MVA/HIV62B VaccineBiological

    Administered by IM injection into the vastus lateralis

  • B63521^11 gp120Biological

    Administered as a IM or SC injection into the vastus lateralis or overlying subcutaneous tissue as the MVA dose

  • IHV01 ProteinBiological

    Administered as a IM or SC injection into the vastus lateralis or overlying subcutaneous tissue as the MVA dose

  • Protein PlaceboBiological

    Sodium Chloride for Injection, 0.9% USP

    Administered as a IM or SC injection into the vastus lateralis or overlying subcutaneous tissue as the MVA dose

Study groups in NCT04041674
Study groupRoleWhat they receive
Group 1 (T1): DNA + MVA + Placebo (IM)ExperimentalParticipants will receive 3 mg of GEO-D02 DNA by intramuscular (IM) injection at Months 0 and 2. Participants will also receive 1×10^8 50% tissue culture infective dose (TCID50) of MVA/HIV62B plus placebo for B63521^11 gp120 plus placebo for IHV01, each by IM injection at Months 4, 6, and 10.
Receives: Biological: GEO-D02 DNA; Biological: MVA/HIV62B Vaccine; Biological: Protein Placebo
Group 2 (T1): DNA + MVA + Placebo (SC)ExperimentalParticipants will receive 3 mg of GEO-D02 DNA by IM injection at Months 0 and 2. Participants will also receive 1×10^8 TCID50 of MVA/HIV62B by IM injection plus placebo for B63521^11 gp120 by subcutaneous (SC) injection plus placebo for IHV01 by SC injection at Months 4, 6, and 10.
Receives: Biological: GEO-D02 DNA; Biological: MVA/HIV62B Vaccine; Biological: Protein Placebo
Group 3 (T2): DNA + MVA + IHV01 + B63ExperimentalParticipants will receive 3 mg of GEO-D02 DNA by IM injection at Months 0 and 2. Participants will also receive 1×10^8 TCID50 of MVA/HIV62B plus 150 mcg of B63521^11 gp120 plus 150 mcg of IHV01, each by IM injection at Months 4, 6, and 10.
Receives: Biological: GEO-D02 DNA; Biological: MVA/HIV62B Vaccine; Biological: B63521^11 gp120; Biological: IHV01 Protein
Group 4 (T3): DNA + MVA +IHV01 + PlaceboExperimentalParticipants will receive 3 mg of GEO-D02 DNA by IM injection at Months 0 and 2. Participants will also receive 1×10^8 TCID50 of MVA/HIV62B plus placebo for B63521^11 gp120 plus 150 mcg of IHV01, each by IM injection at Months 4, 6, and 10.
Receives: Biological: GEO-D02 DNA; Biological: MVA/HIV62B Vaccine; Biological: IHV01 Protein; Biological: Protein Placebo
Group 5 (T4): DNA + MVA +IHV01 (SC)+ B63 (SC)ExperimentalParticipants will receive 3 mg of GEO-D02 DNA by IM injection at Months 0 and 3. Participants will also receive 1×10^8 TCID50 of MVA/HIV62B by IM injection plus 150 mcg of B63521^11 gp120 by SC injection plus 150 mcg of IHV01 by SC injection at Months 4, 6, and 10.
Receives: Biological: GEO-D02 DNA; Biological: MVA/HIV62B Vaccine; Biological: B63521^11 gp120; Biological: IHV01 Protein

What is being measured

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

  1. Frequency of local reactogenicity signs and symptoms

    Local symptoms include pain and/or tenderness at the injection site.

    Measured: Measured through Month 10

  2. Frequency of systemic reactogenicity signs and symptoms

    Systemic symptoms include increased body temperature, malaise and/or fatigue, myalgia, headache, chills, arthralgia, and nausea.

    Measured: Measured through Month 10

  3. Frequency of adverse events

    Summarized using Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class and preferred terms

    Measured: Measured through Month 16

  4. Frequency of serious adverse events

    Summarized using MedDRA System Organ Class and preferred terms

    Measured: Measured through Month 16

  5. HIV-specific IgG binding magnitude to cross-clade panels of gp120 and V1V2, and gp41

    As assessed by binding antibody multiplex assay (BAMA)

    Measured: Measured through Month 10.5

  6. HIV-specific IgG binding response rate to cross-clade panels of gp120 and V1V2, and gp41

    As assessed by BAMA

    Measured: Measured through Month 10.5

  7. HIV-specific IgG binding breadth to cross-clade panels of gp120 and V1V2, and gp41

    As assessed by BAMA

    Measured: Measured through Month 10.5

  8. Response rate of CD4+ T-cell responses to Env

    As assessed by intracellular cytokine staining (ICS)

    Measured: Measured through Month 10.5

  9. Magnitude of CD4+ T-cell responses to Env

    As assessed by ICS

    Measured: Measured through Month 10.5

Secondary outcomes (15)

  1. HIV-specific IgG binding magnitude to V3, CD4i and gp41 IDR

    As assessed by BAMA

    Measured: Measured through Month 10.5

  2. HIV-specific IgG binding response rate to V3, CD4i and gp41 IDR

    As assessed by BAMA

    Measured: Measured through Month 10.5

  3. IgA responses to gp120, V1V2, and gp41

    As assessed by BAMA

    Measured: Measured through Month 10.5

  4. IgG3 responses to gp120, V1V2, and gp41

    As assessed by BAMA

    Measured: Measured through Month 10.5

  5. IgG avidity to defined epitope specificities

    Determined from the immunogenicity data

    Measured: Measured through Month 10.5

  6. HIV-specific IgG binding magnitude to gp120, V1V2, and gp41

    As assessed by BAMA

    Measured: Measured through Month 16

  7. HIV-specific IgG binding response rate to gp120, V1V2, and gp41

    As assessed by BAMA

    Measured: Measured through Month 16

  8. IgA responses to gp120 and gp41

    As assessed by BAMA

    Measured: Measured through Month 16

  9. IgG3 responses to gp120 and gp41

    As assessed by BAMA

    Measured: Measured through Month 16

  10. Response rate of antibody-dependent cellular cytotoxicity (ADCC)-mediating antibody responses

    Assessed using serum samples taken at a primary immunogenicity timepoint

    Measured: Measured through Month 16

  11. Magnitude of ADCC-mediating antibody responses

    Assessed using serum samples taken at a primary immunogenicity timepoint

    Measured: Measured through Month 16

  12. Response rate of antibody-dependent cellular phagocytosis (ADCP)-mediating antibody responses

    Measured using serum samples taken at baseline and at a primary immunogenicity timepoint

    Measured: Measured through Month 16

  13. Magnitude of antibody-dependent cellular phagocytosis (ADCP)-mediating antibody responses

    Measured using serum samples taken at baseline and at a primary immunogenicity timepoint

    Measured: Measured through Month 16

  14. Response rate of vaccine-elicited antibody binding to FcƴR proteins

    Assessed on serum samples taken at the primary immunogenicity timepoints and baseline

    Measured: Measured through Month 16

  15. Magnitude of vaccine-elicited antibody binding to FcƴR proteins

    Assessed on serum samples taken at the primary immunogenicity timepoints and baseline

    Measured: Measured through Month 16

Timeline

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

  1. First posted1 Aug 2019
  2. Study start1 Mar 2022 (estimated)
  3. Primary completion30 Sep 2022 (estimated)
  4. Study completion31 May 2023 (estimated)

Why it stopped: Protocol undergoing additional revisions.

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
Double blind
Who is masked
Participant, Care provider
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04041674
Sponsor's protocol ID
HVTN 132
Other IDs
34571
Status last verified
Oct 2021
First submitted
31 Jul 2019
Last updated
15 Oct 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing GEO-D02 DNA, MVA/HIV62B Vaccine and B63521^11 gp120 in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID).

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 41 inclusion and 54 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: withdrawn, as of the sponsor's last update on 15 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

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?

The study was withdrawn before enrolling participants, so there are no results.

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?

Frequency of local reactogenicity signs and symptoms (time frame: Measured through Month 10). The study lists 9 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 NCT04041674.

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 15 Oct 2021.

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