MalariaPhase 1NCT01018459
Adenovirus Type 35 Based Circumsporozoite Malaria Vaccine in Burkina Faso
A Phase 1 study testing Ad35.CS.01 Circumsporozoite Malaria Vaccine in people with Malaria, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in Burkina Faso.
Trial summary
The purpose of this study is to evaluate the safety of a malaria vaccine, Ad35.CS.01, and how the body reacts to vaccination. Participants will include 48 Berkinabè healthy males and females ages 18-45 years in Burkina Faso. Volunteers for this study will be divided into 4 groups. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Malaria
- What is being tested?
- Ad35.CS.01 Circumsporozoite Malaria Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteBurkina Faso
- Study dates
- Apr 2010to Dec 2011
- 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
- Provision of informed consent before any protocol procedures are performed.
- Males and non-pregnant, non-lactating females between the ages of 18 and 45 years, inclusive.
- Females and males must agree to practice adequate contraception until at least 28 days following their last immunization dose (including abstinence; hormonal contraception; condoms with spermicidal agents; post-menopausal; or surgical sterilization/vasectomy).
- Participants must agree to avoid high risk sexual behavior for exposure to human immunodeficiency virus (HIV).
- In good health as determined by screening medical history, physical examination (PE), and laboratory assessments.
- Willingness to comply with protocol requirements.
- Willingness to be contacted for one year for assessment of serious adverse events.
- Must be a permanent resident of the Saponé health district (villages around Balonghin) in Burkina Faso.
Who cannot join
- Current or recent (within the last four weeks) treatment with parenteral, inhaled, or oral corticosteroids (intranasal steroids are acceptable), or other immunosuppressive agents, or chemotherapy.
- History of splenectomy.
- Abnormal screening laboratory values. Any abnormal screening value for any screening test will exclude the subject from the study. Abnormal screening labs will not be repeated with the exception of high glucose levels will be repeated at a fasting state.
- History of intravenous (IV) drug abuse.
- History of, or current medical, occupational, social or family problems as a result of alcohol or illicit drug use.
- History of moderate to severe mental illness, as defined by symptoms interfering with social or occupational function or suicidal thoughts/attempts.
Show all 22Show fewer
- History of receiving blood or blood products (such as blood transfusion, platelet transfusion, immunoglobulins, hyperimmune serum) in the previous 6 months.
- Vaccination with a live vaccine within the past 30 days or with a nonreplicating, inactivated, or subunit vaccine within the last 14 days.
- Known hypersensitivity to components of the vaccine.
- History of acute or chronic medical conditions including, but not limited to, disorders of the liver, kidney, lung, heart, or nervous system, or other metabolic or autoimmune/inflammatory conditions.
- History of coagulation defect or bleeding from (bruising at) multiple sites that cannot be linked to trauma or surgery.
- History of anaphylaxis or severe hypersensitivity reaction.
- Severe asthma, as defined by an emergency room visit or hospitalization within the last 12 months.
- Pregnant or breastfeeding women.
- Acute illness, including temperature >37.8 degrees Celsius within one week prior to vaccination.
- Positive serology for human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B surface antigen (HBsAg).
- Concurrent participation in other investigational protocols or receipt of an investigational product within the previous 30 days or planned receipt of an investigational product within 28 days following the last immunization dose.
- Identification of any condition that, in the opinion of the investigator, would affect the ability of the subject to understand or comply with the study protocol or would jeopardize the safety or rights of a subject participating in the study.
- History of malignancy, including hematologic and skin cancers (except for a localized basal cell carcinoma), or known immunodeficiency syndrome.
- History of previous receipt of a malaria vaccine.
- Pre-medication with analgesic or antipyretic agents in the 6 hours prior to vaccination, or planned medication with analgesic or antipyretic in the 24 hours following vaccination. This criterion should not preclude subjects receiving such medication if the need arises.
- Receipt of a recombinant adenovirus vector vaccine in a prior study.
Trial locations and contacts
1 site in 1 country.
Burkina Faso1 site
Centre National de Recherche et de Formation sur le Paludisme - Research and Training
West Africa
About this study
Official title: A Phase I Randomized, Controlled, Double-Blinded, Dosage-Escalation Trial to Evaluate the Immunogenicity, Safety, and Reactogenicity of an Adenovirus Type 35 Based Circumsporozoite Malaria Vaccine in Burkinabè, Semi-Immune, Healthy Adults 18 to 45 Years of Age
The purpose of this study is to evaluate the safety of a malaria vaccine, Ad35.CS.01, and how the body reacts to vaccination. Participants will include 48 Berkinabè healthy males and females ages 18-45 years in Burkina Faso. Volunteers for this study will be divided into 4 groups. Members of each group (12 per group) will receive an increasing dose of vaccine or placebo (an inactive substance). Ten will receive the malaria vaccine and 2 will receive placebo. Study procedures include: physical exam, urine sample, and blood samples. Participants will be involved in study related procedures for about 13 months.
Read the detailed description
Malaria currently represents one of the most prevalent infections in tropical and subtropical areas throughout the world. Each year, malaria affects around 300 million people and kills 1 to 3 million people in developing countries. Malaria is caused by the mosquito-borne hematoprotozoan parasites belonging to the genus Plasmodium (P.). Malaria parasites have a life cycle consisting of several stages. Each one of these stages is able to induce specific immune responses against the corresponding stage-specific antigens. Malaria parasites are transmitted to man by several species of female Anopheles mosquitoes. Infected mosquitoes inject the sporozoite form of the malaria parasite into the mammalian bloodstream. Before invading hepatocytes, sporozoites remain for a few minutes in the circulation. At this stage the parasite is located in the extracellular environment and is exposed to antibody attack, mainly directed to the circumsporozoite (CS) protein, a major component of the sporozoite surface. Once in the liver, the parasites replicate and develop into schizonts (up to 20,000 per infected cell). During this intracellular stage of the parasite, the main effectors of the host immune response are T lymphocytes, especially CD8+ T cells. Ad35.CS.01 is a malaria vaccine for which a codon optimized nucleotide sequence representing the P. falciparum circumsporozoite (CS) surface antigen is inserted in a replication deficient Adenovirus 35 backbone. It is hypothesized that the Ad35.CS.01 vaccine will prevent the P. falciparum parasite, which causes malaria, from entering and developing within the liver of those who become infected. Ad35.CS.01 would therefore be expected to reduce malaria-attributable morbidity and mortality. The primary objective is to assess the safety and reactogenicity of 4 ascending dosages of Adenovirus Type 35 circumsporozoite malaria vaccine among healthy, semi-immune, subjects given in 3 doses at 0, 1 and 3 months by intramuscular (IM) injection. The secondary objective is to evaluate the immunogenicity of the Adenovirus Type 35 based circumsporozoite malaria vaccine through performance of Humoral Immune Assays (ELISA [enzyme-linked immunosorbent assay] for antibodies to circumsporozoite antigen and Adenovirus Neutralization Assay for neutralizing antibodies to Adenovirus Type 35) and Cellular Immune Assays (Elispot and Flow Cytometry) for CS-specific CD4+ and CD8+ T cell responses and a whole blood ELISA assay to measure secreted cytokines. This is a phase I randomized, controlled, double-blinded, dosage-escalation trial to evaluate the immunogenicity, safety, and reactogenicity of an Adenovirus Type 35 based circumsporozoite malaria vaccine in Burkinabè, in semi-immune, healthy adults 18 to 45 years of age. Researchers propose to confirm the safety of each dosage of the new vaccine by assessing safety laboratory parameters and reactogenicity for 14 days after the initial dose in the lower dosages before escalating to the next dosage level. Each dosage level group will include 10 subjects given vaccine intramuscularly. Two subjects in each dosage group will receive normal saline as placebo control.
- Conditions
- Malaria
- Being tested
- Ad35.CS.01 Circumsporozoite Malaria Vaccine, Placebo
- Keywords
- malaria, vaccine, Burkina Faso
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ad35.CS.01 Circumsporozoite Malaria VaccineBiological
Ad35.CS.01 appears clear to slightly opalescent with no visible particles. Each 0.75 mL dose of the assigned dosage will be administered via intramuscular injection into the deltoid muscle. Dosages: 10^9 viral particles (vp)/mL, 10^10 vp/mL, 5 x 10^10 vp/mL, and 10^11 vp/mL.
PlaceboDrug
Normal saline placebo control delivered via intramuscular injection into the deltoid muscle.
| Study group | Role | What they receive |
|---|---|---|
| Group D: 10^11 vp/mL or placebo | Experimental | 10 subjects will receive 10^11 vp/mL Ad35.CS.01 and 2 subjects will receive placebo at 0, 1 and 3 months. Receives: Biological: Ad35.CS.01 Circumsporozoite Malaria Vaccine; Drug: Placebo |
| Group A: 10^9 vp/mL or placebo | Experimental | 10 subjects will receive 10^9 viral particles (vp)/mL Ad35.CS.01 and 2 subjects will receive placebo at 0, 1 and 3 months. Receives: Biological: Ad35.CS.01 Circumsporozoite Malaria Vaccine; Drug: Placebo |
| Group B: 10^10 vp/mL or placebo | Experimental | 10 subjects will receive 10^10 vp/mL Ad35.CS.01 and 2 subjects will receive placebo at 0, 1 and 3 months. Receives: Biological: Ad35.CS.01 Circumsporozoite Malaria Vaccine; Drug: Placebo |
| Group C: 5 x 10^10 vp/mL or placebo | Experimental | 10 subjects will receive 5 x 10^10 vp/mL Ad35.CS.01 and 2 subjects will receive placebo at 0, 1 and 3 months. Receives: Biological: Ad35.CS.01 Circumsporozoite Malaria Vaccine; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of subjects experiencing severe (Grade 3) solicited injection site reactions.
Measured: Within 14 days following vaccination.
The number of subjects spontaneously reporting severe (Grade 3) adverse events considered associated with the vaccination.
Measured: At any point during the study period.
The number of subjects experiencing severe (Grade 3) solicited systemic reactions
Measured: Within 14 days following vaccination.
Serious adverse events considered associated with the vaccination reported.
Measured: At any point during the study period.
Secondary outcomes (2)
Neutralizing antibody titers against Adenovirus type 35 by Adenovirus Neutralization Assay.
Measured: At days 0, 28, 56, 84, 112 and 140.
Antibody titers against the malaria circumsporozoite antigen [Geometric Mean Titer and individual log enzyme-linked immunosorbent assay (ELISA) units].
Measured: At days 0, 28, 56, 84, 112 and 140.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2009 (estimated)
- Study startApr 2010
- Primary completionDec 2011
- Study completionDec 2011
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 MalariaStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01018459
- Sponsor's protocol ID
- 08-0037
- Status last verified
- Feb 2012
- First submitted
- 19 Nov 2009
- Last updated
- 6 Jun 2014
- Results posted
- No
Publications
Ouedraogo A, Tiono AB, Kargougou D, Yaro JB, Ouedraogo E, Kabore Y, Kangoye D, Bougouma EC, Gansane A, Henri N, Diarra A, Sanon S, Soulama I, Konate AT, Watson NL, Brown V, Hendriks J, Pau MG, Versteege I, Wiesken E, Sadoff J, Nebie I, Sirima SB. A phase 1b randomized, controlled, double-blinded dosage-escalation trial to evaluate the safety, reactogenicity and immunogenicity of an adenovirus type 35 based circumsporozoite malaria vaccine in Burkinabe healthy adults 18 to 45 years of age. PLoS One. 2013 Nov 11;8(11):e78679. doi: 10.1371/journal.pone.0078679. eCollection 2013.
PubMed 24244339
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Randomized, Controlled, Double-Blinded, Dosage-Escalation Trial to Evaluate the Immunogenicity, Safety, and Reactogenicity of an Adenovirus Type 35 Based Circumsporozoite Malaria Vaccine in Burkinabè, Semi-Immune, Healthy Adults 18 to 45 Years of Age
- ClinicalTrials.gov ID
- NCT01018459
- Acronym / sponsor ID
- 08-0037
- Conditions
- Malaria
- Keywords
- malaria, vaccine, Burkina Faso
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Apr 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 23 Nov 2009 (estimated)
- 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 of a malaria vaccine, Ad35.CS.01, and how the body reacts to vaccination. Participants will include 48 Berkinabè healthy males and females ages 18-45 years in Burkina Faso. Volunteers for this study will be divided into 4 groups. Members of each group (12 per group) will receive an increasing dose of vaccine or placebo (an inactive substance). Ten will receive the malaria vaccine and 2 will receive placebo. Study procedures include: physical exam, urine sample, and blood samples. Participants will be involved in study related procedures for about 13 months.
Detailed description
Malaria currently represents one of the most prevalent infections in tropical and subtropical areas throughout the world. Each year, malaria affects around 300 million people and kills 1 to 3 million people in developing countries. Malaria is caused by the mosquito-borne hematoprotozoan parasites belonging to the genus Plasmodium (P.). Malaria parasites have a life cycle consisting of several stages. Each one of these stages is able to induce specific immune responses against the corresponding stage-specific antigens. Malaria parasites are transmitted to man by several species of female Anopheles mosquitoes. Infected mosquitoes inject the sporozoite form of the malaria parasite into the mammalian bloodstream. Before invading hepatocytes, sporozoites remain for a few minutes in the circulation. At this stage the parasite is located in the extracellular environment and is exposed to antibody attack, mainly directed to the circumsporozoite (CS) protein, a major component of the sporozoite surface. Once in the liver, the parasites replicate and develop into schizonts (up to 20,000 per infected cell). During this intracellular stage of the parasite, the main effectors of the host immune response are T lymphocytes, especially CD8+ T cells. Ad35.CS.01 is a malaria vaccine for which a codon optimized nucleotide sequence representing the P. falciparum circumsporozoite (CS) surface antigen is inserted in a replication deficient Adenovirus 35 backbone. It is hypothesized that the Ad35.CS.01 vaccine will prevent the P. falciparum parasite, which causes malaria, from entering and developing within the liver of those who become infected. Ad35.CS.01 would therefore be expected to reduce malaria-attributable morbidity and mortality. The primary objective is to assess the safety and reactogenicity of 4 ascending dosages of Adenovirus Type 35 circumsporozoite malaria vaccine among healthy, semi-immune, subjects given in 3 doses at 0, 1 and 3 months by intramuscular (IM) injection. The secondary objective is to evaluate the immunogenicity of the Adenovirus Type 35 based circumsporozoite malaria vaccine through performance of Humoral Immune Assays (ELISA [enzyme-linked immunosorbent assay] for antibodies to circumsporozoite antigen and Adenovirus Neutralization Assay for neutralizing antibodies to Adenovirus Type 35) and Cellular Immune Assays (Elispot and Flow Cytometry) for CS-specific CD4+ and CD8+ T cell responses and a whole blood ELISA assay to measure secreted cytokines. This is a phase I randomized, controlled, double-blinded, dosage-escalation trial to evaluate the immunogenicity, safety, and reactogenicity of an Adenovirus Type 35 based circumsporozoite malaria vaccine in Burkinabè, in semi-immune, healthy adults 18 to 45 years of age. Researchers propose to confirm the safety of each dosage of the new vaccine by assessing safety laboratory parameters and reactogenicity for 14 days after the initial dose in the lower dosages before escalating to the next dosage level. Each dosage level group will include 10 subjects given vaccine intramuscularly. Two subjects in each dosage group will receive normal saline as placebo control.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group D: 10^11 vp/mL or placebo | Experimental | Biological: Ad35.CS.01 Circumsporozoite Malaria Vaccine, Drug: Placebo10 subjects will receive 10^11 vp/mL Ad35.CS.01 and 2 subjects will receive placebo at 0, 1 and 3 months. |
| Group A: 10^9 vp/mL or placebo | Experimental | Biological: Ad35.CS.01 Circumsporozoite Malaria Vaccine, Drug: Placebo10 subjects will receive 10^9 viral particles (vp)/mL Ad35.CS.01 and 2 subjects will receive placebo at 0, 1 and 3 months. |
| Group B: 10^10 vp/mL or placebo | Experimental | Biological: Ad35.CS.01 Circumsporozoite Malaria Vaccine, Drug: Placebo10 subjects will receive 10^10 vp/mL Ad35.CS.01 and 2 subjects will receive placebo at 0, 1 and 3 months. |
| Group C: 5 x 10^10 vp/mL or placebo | Experimental | Biological: Ad35.CS.01 Circumsporozoite Malaria Vaccine, Drug: Placebo10 subjects will receive 5 x 10^10 vp/mL Ad35.CS.01 and 2 subjects will receive placebo at 0, 1 and 3 months. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Provision of informed consent before any protocol procedures are performed.
- Males and non-pregnant, non-lactating females between the ages of 18 and 45 years, inclusive.
- Females and males must agree to practice adequate contraception until at least 28 days following their last immunization dose (including abstinence; hormonal contraception; condoms with spermicidal agents; post-menopausal; or surgical sterilization/vasectomy).
- Participants must agree to avoid high risk sexual behavior for exposure to human immunodeficiency virus (HIV).
- In good health as determined by screening medical history, physical examination (PE), and laboratory assessments.
Key exclusion criteria (22 listed)
- Current or recent (within the last four weeks) treatment with parenteral, inhaled, or oral corticosteroids (intranasal steroids are acceptable), or other immunosuppressive agents, or chemotherapy.
- History of splenectomy.
- Abnormal screening laboratory values. Any abnormal screening value for any screening test will exclude the subject from the study. Abnormal screening labs will not be repeated with the exception of high glucose levels will be repeated at a fasting state.
- History of intravenous (IV) drug abuse.
- History of, or current medical, occupational, social or family problems as a result of alcohol or illicit drug use.
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 |
|---|---|---|
| Ad35.CS.01 Circumsporozoite Malaria VaccineAd35.CS.01 appears clear to slightly opalescent with no visible particles. Each 0.75 mL dose of the assigned dosage will be administered via intramuscular injection into the deltoid muscle. Dosages: 10^9 viral particles (vp)/mL, 10^10 vp/mL, 5 x 10^10 vp/mL, and 10^11 vp/mL. | Biological | Group A: 10^9 vp/mL or placebo, Group B: 10^10 vp/mL or placebo, Group C: 5 x 10^10 vp/mL or placebo, Group D: 10^11 vp/mL or placebo |
| PlaceboNormal saline placebo control delivered via intramuscular injection into the deltoid muscle. | Drug | Group A: 10^9 vp/mL or placebo, Group B: 10^10 vp/mL or placebo, Group C: 5 x 10^10 vp/mL or placebo, Group D: 10^11 vp/mL or placebo |
Primary outcome
The number of subjects experiencing severe (Grade 3) solicited injection site reactions.
Time frame: Within 14 days following vaccination.
The number of subjects spontaneously reporting severe (Grade 3) adverse events considered associated with the vaccination.
Time frame: At any point during the study period.
The number of subjects experiencing severe (Grade 3) solicited systemic reactions
Time frame: Within 14 days following vaccination.
Serious adverse events considered associated with the vaccination reported.
Time frame: At any point during the study period.
2 secondary outcomes
Neutralizing antibody titers against Adenovirus type 35 by Adenovirus Neutralization Assay.
Time frame: At days 0, 28, 56, 84, 112 and 140.
Antibody titers against the malaria circumsporozoite antigen [Geometric Mean Titer and individual log enzyme-linked immunosorbent assay (ELISA) units].
Time frame: At days 0, 28, 56, 84, 112 and 140.
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 6 Jun 2014.
- Results publication: PubMed 24244339Ouedraogo A, Tiono AB, Kargougou D, Yaro JB, Ouedraogo E, Kabore Y, Kangoye D, Bougouma EC, Gansane A, Henri N, Diarra A, Sanon S, Soulama I, Konate AT, Watson NL, Brown V, Hendriks J, Pau MG, Versteege I, Wiesken E, Sadoff J, Nebie I, Sirima SB. A phase 1b randomized, controlled, double-blinded dosage-escalation trial to evaluate the safety, reactogenicity and immunogenicity of an adenovirus type 35 based circumsporozoite malaria vaccine in Burkinabe healthy adults 18 to 45 years of age. PLoS One. 2013 Nov 11;8(11):e78679. doi: 10.1371/journal.pone.0078679. eCollection 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Ad35.CS.01 Circumsporozoite Malaria Vaccine in people with Malaria, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in Burkina Faso.
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 8 inclusion and 22 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 6 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Burkina Faso. 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. 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?
The number of subjects experiencing severe (Grade 3) solicited injection site reactions. (time frame: Within 14 days following vaccination.). The study lists 4 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 NCT01018459, 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 6 Jun 2014.