Papillomavirus InfectionsPhase 1NCT03929172
A Study of Safety, Tolerability and Immunogenicity of HPV-L2 Vaccine in Healthy Adult Male and Female Subjects
A Phase 1 study testing AAVLP-HPV in people with Papillomavirus Infections, run by 2A Pharma AB at 1 site in United Kingdom.
Trial summary
The purpose of this study is to evaluate the safety, tolerability, and the immunological effects of adeno-associated virus-like particle human papillomavirus (AAVLP-HPV) vaccine in healthy adults. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Papillomavirus Infections
- What is being tested?
- AAVLP-HPV
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 28 Feb 2019to 29 May 2020
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects must fulfill all of the following inclusion criteria to be eligible for participation in the study:
- Healthy, adult, male or female aged between 18 and 45 years, inclusive, at screening.
- Body Mass Index (BMI) ≥ 18 and ≤ 32.0 kg/m2 at screening.
- Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or ECGs, as deemed by the PI or designee.
- For a female of childbearing potential: either be sexually inactive (abstinent as a lifestyle*) for 28 days prior to the first dosing and throughout the study or be using one of the following acceptable birth control methods:
- hormonal oral contraceptives, vaginal ring, transdermal patch, or hormone releasing intrauterine device for at least 3 months prior to the first dosing with either a physical (e.g., condom, diaphragm, or other) or a chemical (e.g., spermicide) barrier method from the time of screening and throughout the study.
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- depot/implantable hormone (e.g., Depo-provera®, Implanon) for at least 3 months prior to the first dosing and throughout the study.
- In addition, female subjects of childbearing potential will be advised to remain sexually inactive or to keep the same birth control method for at least 28 days following the last dose.
- True abstinence is defined as refraining from heterosexual intercourse in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods), declaration of abstinence for the duration of exposure to study drug, and withdrawal are not acceptable methods of contraception.
- For a female of non-childbearing potential: must have undergone one of the following sterilization procedures at least 6 months prior to the first dosing:
- hysteroscopic sterilization;
- bilateral tubal ligation or bilateral salpingectomy;
- hysterectomy;
- bilateral oophorectomy; or be postmenopausal with amenorrhea for at least 1 year prior to the first dosing and follicle-stimulating hormone (FSH) serum levels consistent with postmenopausal status.
- Understands the study procedures in the informed consent form (ICF), and be willing and able to comply with the protocol.
Who cannot join
- Subjects must not be enrolled in the study if they meet any of the following criteria:
- Is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study.
- History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI or designee.
- History of any illness that, in the opinion of the PI or designee, might confound the results of the study or poses an additional risk to the subject by their participation in the study.
- History or presence of alcoholism or drug abuse within the past 2 years prior to the first dosing.
- History or presence of hypersensitivity or idiosyncratic reaction to the study drugs or related compounds.
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- Prior vaccination against HPV.
- Positive for HPV antibodies against HPV types 6, 11, 16, and 18.
- Have received an investigational vaccination within 90 days before screening.
- Have received any licensed vaccination within 30 days before screening.
- Any condition that may interfere with the intended administration of the study drug.
- Suffered from febrile or infectious illness within 7 days prior to Day 1.
- Subjects who plan to become pregnant/start a family during the study.
- Female subjects with a positive pregnancy test or who are lactating.
- Drink alcohol in excess of 21 glasses/units (425 g) per week for males or 14 glasses/units (284 g) per week for females, with one unit = 150 mL of wine or 360 mL of beer or 45 mL of 45% alcohol.
- Positive urine drug or alcohol results at screening or Day -1.
- Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV).
- Seated blood pressure is less than 90/40 mmHg or greater than 140/90 mmHg at screening.
- Seated heart rate is lower than 40 bpm or higher than 99 bpm at screening.
- QTcF interval is >460 msec (males) or >470 msec (females) or has ECG findings deemed abnormal with clinical significance by the PI or designee at screening.
- Unable to refrain from or anticipates the use of any drug, including prescription and non-prescription medications, herbal remedies, or vitamin supplements that could adversely affect the immune system during 3 months prior to vaccination and throughout the study. Inhaled and topical corticosteroids will be allowed. Medication listed as part of acceptable birth control methods and hormone replacement therapy will be allowed. After randomization, acetaminophen (up to 2 g per 24 hours) may be administered at the discretion of the PI or designee. Appropriate sources will be consulted by the PI or designee to confirm interaction with study drugs. Subjects may not initiate new prescription medication within 1 month prior to screening, with exceptions, or must be on a stable dose for at least 90 days prior to vaccination as approved in advance by the PI or designee.
- Donation of blood or plasma within 90 days prior to the first dosing.
- Donation of bone marrow within the last 6 months prior to the first dosing.
- Participation in another clinical study with an investigational agent within the 90 days prior to first dosing. The 90-day window will be derived from the date of the last dosing, whichever is later, in the previous study to Day 1 of the current study.
- Has tattoo(s) or scarring at or near the site of vaccine administration or any other condition which may interfere with injection site examination, in the opinion of the PI.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A First-in-Human, Phase 1, Randomized, Placebo-Controlled, Double-Blind Study to Assess the Safety and Tolerability, and to Explore Immunological Effects of I.M. Administered AAVLP-HPV Vaccine in Healthy Adult Male and Female Subjects
The purpose of this study is to evaluate the safety, tolerability, and the immunological effects of adeno-associated virus-like particle human papillomavirus (AAVLP-HPV) vaccine in healthy adults.
Read the detailed description
2A Pharma's AAVLP-HPV vaccine candidate is based on AAVLPs with insertion of sequences of the L2 minor HPV capsid protein. The vaccine's intended clinical use is as a vaccine for prophylaxis against HPV infection in adolescents and adults.
This is a 12 month single-center, randomized, placebo-controlled, double-blind, repeated dose, safety, tolerability, and immunological effect study. Twenty (20) healthy, adult male and female subjects will be enrolled with a minimum of 40% of each gender. Sixteen (16) subjects will be randomized to receive the active drug and 4 subjects to receive the placebo. At least 1 subject of each gender will be randomized to receive the placebo.
Subjects will receive a total of 3 doses of AAVLP-HPV or placebo: a prime on Day 1, and two boosts, one on Day 57 (±2 days) and one on Day 180 (±1 week). The volunteers will be followed until day 365 (±1 week) when they return for the final safety and serum-based immunogenicity and neutralising antibodies assessment.
- Conditions
- Papillomavirus Infections
- Being tested
- AAVLP-HPV, Placebo
- Keywords
- HPV-L2
- Medical subject headings
- Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AAVLP-HPVBiological
Also called 2AP01
20μg/injection formulated in a ready to use solution containing 100mM sodium citrate, 2.5 mM MgCl2, 0.001% pluronic F-68, pH 6.0 for i.m. injection as 0.5 mL per injection.
PlaceboDrug
0.5 mL 100 mM Sodium Citrate, 2.5 mM MgCl2, 0.001% Pluronic F-68, pH 6 for i.m. injection as 0.5 mL per injection.
| Study group | Role | What they receive |
|---|---|---|
| AAVLP-HPV Vaccine Arm | Experimental | Subjects will receive a total of 3 vaccinations: a prime on Day 1, and boosts on Day 57 (± 2 days) and Day 180 (± 1 week). Receives: Biological: AAVLP-HPV |
| Placebo Arm | Placebo comparator | Subjects will receive a total of 3 vaccinations: a prime on Day 1, and boosts on Day 57 (± 2 days) and Day 180 (± 1 week). Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Subjects Reporting Solicited Local Symptoms
Solicited local symptoms assessed including pain, tenderness, redness, swelling, and induration.
Measured: Day 0 and 1 after each vaccination
Percentage of Subjects Reporting Solicited General Symptoms
Solicited general symptoms assessed including fever, headache, fatigue, nausea, diarrhea, vomiting, myalgia, allergic reaction.
Measured: Through 365 days
Percentage of Subjects Reporting Unsolicited Adverse Events (AEs)
An unsolicited adverse event is defined as any adverse event (AE) reported in addition to those solicited during the clinical study.
Measured: Through 365 days
Percentage of Subjects Reporting New Onset of Chronic Illness (NOCI)
A NOCI is defined as diagnosis post study drug administration of a new medical condition, which is chronic in nature, including those potentially controllable by medication (e.g., diabetes, asthma)
Measured: Through 365 days
Percentage of Subjects Reporting Adverse Events of Special Interest (AESI)
An AESI should not necessarily be classified to be a serious adverse event, even though the event may be clinically significant. If an AESI is reported, the Sponsor should be promptly informed and information relevant to the event should be promptly collected using the same process as that used for reporting serious adverse events. For this protocol, AESI includes demyelinating syndromes or neurological conditions such as complex regional pain or postural orthostatic tachycardia syndromes.
Measured: Through 365 days
Percentage of Subjects Reporting Serious Adverse Events (SAEs)
SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above.
Measured: Through 365 days
Vital Signs - Body Temperature
Single measurements of body temperature 35.6 ≤ Temperature ≤37.7 (C)
Measured: Through 365 days
Vital Signs - Respiratory Rate
Measurements of respiratory rate 8≤ Respiration ≤24 (breaths/min)
Measured: Through 365 days
Vital Signs - Blood Pressure
Measurements of blood pressure 90≤ Systolic ≤140 (mmHg) and 40≤ Diastolic ≤90 (mmHg
Measured: Through 365 days
Vital Signs - Heart Rate
Measurements of 40≤ Pulse ≤99 (beats/min)
Measured: Through 365 days
Vital Signs - Body Mass Index (BMI
Calculated as weight in kg / height in meters^2
Measured: Through 365 days
Electrocardiogram (ECG)
Single 12-lead ECGs will be performed. Measurement type must be one of the following: HR (50≤HR≤100 [beats/min]], PR (110≤PR≤219 [ms]), QRS (QRS<110 [ms]), QT, QTcF (QTcF for Male<460 and for Female<470 [ms]), or overall interpretation.
Measured: Through 365 days
Physical examination
A full best practice physical examination will be performed by the PI
Measured: Through 365 days
Clinical Laboratory Tests
Measurements of clinical laboratory abnormalities
Measured: Through 365 days
Secondary outcomes (2)
Evaluation of immunogenicity using a humoral immune function ELISA assay from serum
Immunogenicity is measured as having generated anti-HPV type16 L2 and HPV type 31 L2 antibodies after vaccination. The antibody response is measured as a titer.
Measured: Through 365 days
Evaluation of HPV-Neutralizing Antibodies using an in vitro Pseudovirion-Based HPV-Neutralization Assay (PBNA)
Neutralization is measured as having induced anti-HPV antibodies able to protect/neutralize HPV infection in vitro. The neutralization antibody titers are presented as the IC50 titer.
Measured: Through 365 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2019
- Study start28 Feb 2019
- Primary completion29 May 2020
- Study completion29 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Papillomavirus InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- 2A Pharma AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Celerion
- Responsible party
- Sponsor
- Investigators
- John Nieland, Study chair, 2A Pharma ABDavid Bell, Principal investigator, Celerion, CRO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03929172
- Sponsor's protocol ID
- 2AP01-01
- Other IDs
- 2018-003045-42, 2018
- Status last verified
- Jun 2020
- First submitted
- 12 Apr 2019
- Last updated
- 1 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Alvarez J, Olczak P, Tsai H-L, Terrell J, Wong M, Tsingine H, Palande V, Prangsgaard J, Huus E, Muller M, Nieland JDV, Roden RBS. Factors impacting protective immunity conferred by vaccination with adeno-associated virus-like particles displaying human papillomavirus L2 residues 17-36. J Virol. 2026 Aug 21:e0044826. doi: 10.1128/jvi.00448-26. Online ahead of print.
PubMed 42627231
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-in-Human, Phase 1, Randomized, Placebo-Controlled, Double-Blind Study to Assess the Safety and Tolerability, and to Explore Immunological Effects of I.M. Administered AAVLP-HPV Vaccine in Healthy Adult Male and Female Subjects
- ClinicalTrials.gov ID
- NCT03929172
- Acronym / sponsor ID
- 2AP01-01
- Conditions
- Papillomavirus Infections
- Keywords
- HPV-L2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- 2A Pharma ABIndustry (pharma, biotech, devices)
- Collaborators
- Celerion
- Study start
- 28 Feb 2019 (actual)
- Primary completion
- 29 May 2020 (actual)
- Study completion
- 29 May 2020 (actual)
- First posted
- 26 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety, tolerability, and the immunological effects of adeno-associated virus-like particle human papillomavirus (AAVLP-HPV) vaccine in healthy adults.
Detailed description
2A Pharma's AAVLP-HPV vaccine candidate is based on AAVLPs with insertion of sequences of the L2 minor HPV capsid protein. The vaccine's intended clinical use is as a vaccine for prophylaxis against HPV infection in adolescents and adults.
This is a 12 month single-center, randomized, placebo-controlled, double-blind, repeated dose, safety, tolerability, and immunological effect study. Twenty (20) healthy, adult male and female subjects will be enrolled with a minimum of 40% of each gender. Sixteen (16) subjects will be randomized to receive the active drug and 4 subjects to receive the placebo. At least 1 subject of each gender will be randomized to receive the placebo.
Subjects will receive a total of 3 doses of AAVLP-HPV or placebo: a prime on Day 1, and two boosts, one on Day 57 (±2 days) and one on Day 180 (±1 week). The volunteers will be followed until day 365 (±1 week) when they return for the final safety and serum-based immunogenicity and neutralising antibodies assessment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AAVLP-HPV Vaccine Arm | Experimental | Biological: AAVLP-HPVSubjects will receive a total of 3 vaccinations: a prime on Day 1, and boosts on Day 57 (± 2 days) and Day 180 (± 1 week). |
| Placebo Arm | Placebo comparator | Drug: PlaceboSubjects will receive a total of 3 vaccinations: a prime on Day 1, and boosts on Day 57 (± 2 days) and Day 180 (± 1 week). |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- Subjects must fulfill all of the following inclusion criteria to be eligible for participation in the study:
- Healthy, adult, male or female aged between 18 and 45 years, inclusive, at screening.
- Body Mass Index (BMI) ≥ 18 and ≤ 32.0 kg/m2 at screening.
- Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or ECGs, as deemed by the PI or designee.
- For a female of childbearing potential: either be sexually inactive (abstinent as a lifestyle*) for 28 days prior to the first dosing and throughout the study or be using one of the following acceptable birth control methods:
Key exclusion criteria (25 listed)
- Is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study.
- History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI or designee.
- History of any illness that, in the opinion of the PI or designee, might confound the results of the study or poses an additional risk to the subject by their participation in the study.
- History or presence of alcoholism or drug abuse within the past 2 years prior to the first dosing.
- History or presence of hypersensitivity or idiosyncratic reaction to the study drugs or related compounds.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AAVLP-HPVAlso: 2AP0120μg/injection formulated in a ready to use solution containing 100mM sodium citrate, 2.5 mM MgCl2, 0.001% pluronic F-68, pH 6.0 for i.m. injection as 0.5 mL per injection. | Biological | AAVLP-HPV Vaccine Arm |
| Placebo0.5 mL 100 mM Sodium Citrate, 2.5 mM MgCl2, 0.001% Pluronic F-68, pH 6 for i.m. injection as 0.5 mL per injection. | Drug | Placebo Arm |
Primary outcome
Percentage of Subjects Reporting Solicited Local Symptoms
Time frame: Day 0 and 1 after each vaccination
Solicited local symptoms assessed including pain, tenderness, redness, swelling, and induration.
Percentage of Subjects Reporting Solicited General Symptoms
Time frame: Through 365 days
Solicited general symptoms assessed including fever, headache, fatigue, nausea, diarrhea, vomiting, myalgia, allergic reaction.
Percentage of Subjects Reporting Unsolicited Adverse Events (AEs)
Time frame: Through 365 days
An unsolicited adverse event is defined as any adverse event (AE) reported in addition to those solicited during the clinical study.
Percentage of Subjects Reporting New Onset of Chronic Illness (NOCI)
Time frame: Through 365 days
A NOCI is defined as diagnosis post study drug administration of a new medical condition, which is chronic in nature, including those potentially controllable by medication (e.g., diabetes, asthma)
Percentage of Subjects Reporting Adverse Events of Special Interest (AESI)
Time frame: Through 365 days
An AESI should not necessarily be classified to be a serious adverse event, even though the event may be clinically significant. If an AESI is reported, the Sponsor should be promptly informed and information relevant to the event should be promptly collected using the same process as that used for reporting serious adverse events. For this protocol, AESI includes demyelinating syndromes or neurological conditions such as complex regional pain or postural orthostatic tachycardia syndromes.
Percentage of Subjects Reporting Serious Adverse Events (SAEs)
Time frame: Through 365 days
SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above.
Vital Signs - Body Temperature
Time frame: Through 365 days
Single measurements of body temperature 35.6 ≤ Temperature ≤37.7 (C)
Vital Signs - Respiratory Rate
Time frame: Through 365 days
Measurements of respiratory rate 8≤ Respiration ≤24 (breaths/min)
Vital Signs - Blood Pressure
Time frame: Through 365 days
Measurements of blood pressure 90≤ Systolic ≤140 (mmHg) and 40≤ Diastolic ≤90 (mmHg
Vital Signs - Heart Rate
Time frame: Through 365 days
Measurements of 40≤ Pulse ≤99 (beats/min)
Vital Signs - Body Mass Index (BMI
Time frame: Through 365 days
Calculated as weight in kg / height in meters^2
Electrocardiogram (ECG)
Time frame: Through 365 days
Single 12-lead ECGs will be performed. Measurement type must be one of the following: HR (50≤HR≤100 [beats/min]], PR (110≤PR≤219 [ms]), QRS (QRS<110 [ms]), QT, QTcF (QTcF for Male<460 and for Female<470 [ms]), or overall interpretation.
Physical examination
Time frame: Through 365 days
A full best practice physical examination will be performed by the PI
Clinical Laboratory Tests
Time frame: Through 365 days
Measurements of clinical laboratory abnormalities
2 secondary outcomes
Evaluation of immunogenicity using a humoral immune function ELISA assay from serum
Time frame: Through 365 days
Evaluation of HPV-Neutralizing Antibodies using an in vitro Pseudovirion-Based HPV-Neutralization Assay (PBNA)
Time frame: Through 365 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2020.
- Derived from this study: PubMed 42627231Alvarez J, Olczak P, Tsai H-L, Terrell J, Wong M, Tsingine H, Palande V, Prangsgaard J, Huus E, Muller M, Nieland JDV, Roden RBS. Factors impacting protective immunity conferred by vaccination with adeno-associated virus-like particles displaying human papillomavirus L2 residues 17-36. J Virol. 2026 Aug 21:e0044826. doi: 10.1128/jvi.00448-26. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Nieland study chair
2A Pharma AB
David Bell principal investigator
Celerion, CRO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AAVLP-HPV in people with Papillomavirus Infections, run by 2A Pharma AB 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 15 inclusion and 25 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 1 Jul 2020. 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?
Percentage of Subjects Reporting Solicited Local Symptoms (time frame: Day 0 and 1 after each vaccination). The study lists 14 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 NCT03929172, which also lists 1 linked publication.
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 1 Jul 2020.