Colon CancerPhase 1NCT01972737
Phase I Study of Ad5-hGCC (Human Guanylyl Cyclase C)-PADRE in Stage I/II Colon Cancer
A Phase 1 study testing Ad5-hGCC-PADRE vaccine in people with Colon Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University at 1 site in United States.
Trial summary
The purpose of this study is to determine the safety, tolerability and ability to stimulate hGCC-specific antibody and killer T cell immune responses of an Ad5-hGCC-PADRE vaccine in stage I and stage II Caucasian and African American colon cancer patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Cancer
- What is being tested?
- Ad5-hGCC-PADRE vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to 13 Jan 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and Female African American or Caucasian subjects older than 18 years of age. Race will be defined by the subject.
- Stage I or stage II (pN0) colon cancer within 3 years of surgery
- Competent immune system, defined by the ability to make a delayed type hypersensitivity (DTH) reaction to at least one of the following: candida, mumps, tetanus or trichophyton
- Adequate renal, liver, and bone marrow functions:
- Serum creatinine ≤ 2.0 mg/dl, Hemoglobin ≥ 10.0 g/dl WBC (white blood cells) ≥ 3,000 /mm3, platelet count ≥ 100,000/mm3, total bilirubin ≤2.0 mg/ml, and albumin ≥ 3.0 g/dl
- Lymph node specimens available for quantification of occult metastases
Show all 11Show fewer
- Minimum of 2 months and maximum of 36 months since surgery
- No clinical or laboratory evidence of local or systemic recurrence at entry to the study
- Expected survival of at least 6 months
- Karnofsky performance status ≥ 80 (ECOG 0 or 1)
- Willingness and ability to understand and give informed consent and follow the procedures described in the protocol
Who cannot join
- Failure to meet any of the inclusion criteria above
- Rectal cancer
- Prior chemotherapy/radiotherapy/immunotherapy/experimental medications for colon cancer
- Prior splenectomy
- Concurrent use of systemic steroids or immunosuppressive drugs (Note: topical or inhaled aerosol steroid therapies are not contraindicated for participation in the study)
- HIV-positive by ELISA, confirmed by Western blot
Show all 14Show fewer
- Active autoimmune diseases that the Investigator considers would interfere with an immunologic response (e.g., systemic lupus erythematosus, multiple sclerosis or ankylosing spondylitis)
- Other malignancy within 5 years except curatively treated non-melanomatous skin cancer and curatively treated carcinoma in situ of the uterine cervix, or early stage (stage A or B1) prostate cancer
- Medically-proven inflammatory bowel disease
- Has at the time of enrollment, serious infection or other serious medical condition that implies a survival of less than six months
- Pregnancy or lactation (serum B-human chorionic gonadotropin test must be negative in fertile women at screening visit). Subjects will be asked to use contraception during conduct of the study.
- Past medical history of serious reaction to adenovirus vaccine
- Mental handicap
- Chronic diarrhea >6 times per day
Trial locations and contacts
1 site in 1 country.
United States1 site
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
About this study
Official title: A Phase I Study of Guanylyl Cyclase C (GCC)-Encoding Replication-Deficient Human Type 5 Recombinant Adenovirus Vaccine (Ad5-hGCC-PADRE) in Stage I and II Colon Cancer Patients
The purpose of this study is to determine the safety, tolerability and ability to stimulate hGCC-specific antibody and killer T cell immune responses of an Ad5-hGCC-PADRE vaccine in stage I and stage II Caucasian and African American colon cancer patients.
Read the detailed description
There is an unmet need for improved therapeutic paradigms in colorectal cancer, the 3rd leading cause of cancer and 2nd leading cause of cancer mortality worldwide. This need is underscored by the populations in jeopardy, including the ~100 million people in the US over 50 y that have a 1:8 risk associated with a disease-specific mortality of 50%. Mortality reflects metastatic disease: ~50% of patients initially present with regional or distant metastases, while ~20% present with occult metastases. Beyond the general population risk, there is an established stage-specific difference in outcomes in pN0 (node negative) African Americans with colorectal cancer, who exhibit ~40% excess mortality attributable to race. Reductions in mortality have been hampered by the absence of effective chemo-, radio-, and immuno- therapeutic approaches to metastatic disease. In that context, immunotherapy has been disappointing, in part, reflecting the absence of antigens that are tumor-specific, immunogenic, and universally associated with neoplasia. Moreover, the gap in survival between African Americans and Caucasians specifically reflects the inability to identify those with occult metastases who are at increased risk for developing recurrent disease.
This study advances an emerging paradigm in colorectal cancer cell detection and eradication, employing GCC as a molecular marker and immunological target. GCC is a protein whose expression is normally restricted to intestinal epithelial cells, but universally expressed by metastatic colorectal tumors. We have clinically validated the detection of occult metastases in lymph nodes by quantifying GCC mRNA (messenger RNA) by reverse transcriptase (RT)-PCR (qRT-PCR). This study revealed that occult metastases were the most powerful independent predictors of survival in pN0 patients. Further, there is a disproportionate burden of occult disease in African American, compared to Caucasian, patients. This new molecular staging platform provides a unique opportunity to identify occult metastases underlying racial disparities in disease recurrence, which could be prevented by tumor-targeted immunotherapy.
In the absence of ideal tumor antigens, immunotherapy has been directed to tissue-specific proteins. Barriers to employing self-antigens include tolerance, which limits anti-tumor immunity, and autoimmunity. The present study advances an emerging paradigm exploiting immunological compartmentalization of mucosally-restricted antigens to generate systemic antitumor immunity without autoimmunity. Asymmetry in immunological cross-talk between compartments, wherein systemic T and B cell responses rarely extend to mucosae, suggest that proteins normally expressed in mucosae, but which are expressed systemically by tumors, may serve as vaccine targets for metastases. Advantages of these cancer mucosa antigens include unique systemic immunoreactivity profiles supporting highly effective durable antitumor immunity in the context of absent immunological cross-talk between compartments restricting autoimmunity. Here, this paradigm will be advanced employing the tumor marker GCC, which induces immune responses that oppose metastatic colorectal cancer in preclinical models, without autoimmunity. This study will define the safety and immunological efficacy of adenoviral GCC vaccine in African American and Caucasian pN0 colon cancer patients with excess recurrence risk reflecting occult lymph node metastases identified by GCC qRT-PCR. This study will be the first step in translating GCC into a vaccine for the secondary prevention of metastases in African American and Caucasian colorectal cancer patients.
- Conditions
- Colon Cancer
- Being tested
- Ad5-hGCC-PADRE vaccine
- Keywords
- Vaccine, Colon cancer, safety, tolerability, antibody responses, T cell responses
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ad5-hGCC-PADRE vaccineBiological
A single intramuscular dose (100 billion virus particles) of Ad5-hGCC-PADRE vaccine.
| Study group | Role | What they receive |
|---|---|---|
| Ad5-hGCC-PADRE Vaccine | Experimental | Active vaccine Receives: Biological: Ad5-hGCC-PADRE vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Quantify treatment-emergent and related acute and sub-acute adverse events, serious adverse events, and Grade 3 and 4 non-laboratory abnormalities for safety assessments during the 6-month period after the injection of Ad5-hGCC-PADRE.
Measured: Continuous for 6 months after vaccination.
Antibody responses
Determine whether Ad5-hGCC-PADRE induces an antibody response to GCC at 1 month following vaccination with Ad5-hGCC-PADRE.
Measured: One month following vaccination.
Secondary outcomes (2)
T cell responses
Determine whether Ad5-hGCC-PADRE induces a T cell response to GCC at 1 month following vaccination.
Measured: One month following vaccination.
Persistent immunological responses
Determine whether Ad5-hGCC-PADRE induces antibody and/or T cell responses to GCC that persist at 3 months and 6 months following vaccination.
Measured: Three and six months after vaccination.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2013 (estimated)
- Study startOct 2013
- Primary completion3 Jun 2014
- Study completion13 Jan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Colon CancerStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Scott A Waldman, MD, PhD, Study director, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01972737
- Sponsor's protocol ID
- 13S.462
- Other IDs
- SAP #4100051723, JT 2657
- Status last verified
- May 2025
- First submitted
- 24 Oct 2013
- Last updated
- 2 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Waldman SA, Hyslop T, Schulz S, Barkun A, Nielsen K, Haaf J, Bonaccorso C, Li Y, Weinberg DS. Association of GUCY2C expression in lymph nodes with time to recurrence and disease-free survival in pN0 colorectal cancer. JAMA. 2009 Feb 18;301(7):745-52. doi: 10.1001/jama.2009.141.
PubMed 19224751Snook AE, Magee MS, Marszalowicz GP, Schulz S, Waldman SA. Epitope-targeted cytotoxic T cells mediate lineage-specific antitumor efficacy induced by the cancer mucosa antigen GUCY2C. Cancer Immunol Immunother. 2012 May;61(5):713-23. doi: 10.1007/s00262-011-1133-0. Epub 2011 Nov 6.
PubMed 22057677Snook AE, Li P, Stafford BJ, Faul EJ, Huang L, Birbe RC, Bombonati A, Schulz S, Schnell MJ, Eisenlohr LC, Waldman SA. Lineage-specific T-cell responses to cancer mucosa antigen oppose systemic metastases without mucosal inflammatory disease. Cancer Res. 2009 Apr 15;69(8):3537-44. doi: 10.1158/0008-5472.CAN-08-3386. Epub 2009 Apr 7.
PubMed 19351847Snook AE, Huang L, Schulz S, Eisenlohr LC, Waldman SA. Cytokine adjuvanation of therapeutic anti-tumor immunity targeted to cancer mucosa antigens. Clin Transl Sci. 2008 Dec;1(3):263-4. doi: 10.1111/j.1752-8062.2008.00054.x.
PubMed 19956776Snook AE, Stafford BJ, Eisenlohr LC, Rothstein JL, Waldman SA. Mucosally restricted antigens as novel immunological targets for antitumor therapy. Biomark Med. 2007 Jun;1(1):187-202. doi: 10.2217/17520363.1.1.187.
PubMed 20477468Snook AE, Stafford BJ, Li P, Tan G, Huang L, Birbe R, Schulz S, Schnell MJ, Thakur M, Rothstein JL, Eisenlohr LC, Waldman SA. Guanylyl cyclase C-induced immunotherapeutic responses opposing tumor metastases without autoimmunity. J Natl Cancer Inst. 2008 Jul 2;100(13):950-61. doi: 10.1093/jnci/djn178. Epub 2008 Jun 24.
PubMed 18577748Snook AE, Baybutt TR, Xiang B, Abraham TS, Flickinger JC Jr, Hyslop T, Zhan T, Kraft WK, Sato T, Waldman SA. Split tolerance permits safe Ad5-GUCY2C-PADRE vaccine-induced T-cell responses in colon cancer patients. J Immunother Cancer. 2019 Apr 23;7(1):104. doi: 10.1186/s40425-019-0576-2.
PubMed 31010434Myers RE, Wolf T, Shwae P, Hegarty S, Peiper SC, Waldman SA. A survey of physician receptivity to molecular diagnostic testing and readiness to act on results for early-stage colon cancer patients. BMC Cancer. 2016 Oct 3;16(1):766. doi: 10.1186/s12885-016-2812-1.
PubMed 27716119
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Guanylyl Cyclase C (GCC)-Encoding Replication-Deficient Human Type 5 Recombinant Adenovirus Vaccine (Ad5-hGCC-PADRE) in Stage I and II Colon Cancer Patients
- ClinicalTrials.gov ID
- NCT01972737
- Acronym / sponsor ID
- 13S.462
- Conditions
- Colon Cancer
- Keywords
- Vaccine, Colon cancer, safety, tolerability, antibody responses, T cell responses
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- 3 Jun 2014 (actual)
- Study completion
- 13 Jan 2016 (actual)
- First posted
- 30 Oct 2013 (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 determine the safety, tolerability and ability to stimulate hGCC-specific antibody and killer T cell immune responses of an Ad5-hGCC-PADRE vaccine in stage I and stage II Caucasian and African American colon cancer patients.
Detailed description
There is an unmet need for improved therapeutic paradigms in colorectal cancer, the 3rd leading cause of cancer and 2nd leading cause of cancer mortality worldwide. This need is underscored by the populations in jeopardy, including the ~100 million people in the US over 50 y that have a 1:8 risk associated with a disease-specific mortality of 50%. Mortality reflects metastatic disease: ~50% of patients initially present with regional or distant metastases, while ~20% present with occult metastases. Beyond the general population risk, there is an established stage-specific difference in outcomes in pN0 (node negative) African Americans with colorectal cancer, who exhibit ~40% excess mortality attributable to race. Reductions in mortality have been hampered by the absence of effective chemo-, radio-, and immuno- therapeutic approaches to metastatic disease. In that context, immunotherapy has been disappointing, in part, reflecting the absence of antigens that are tumor-specific, immunogenic, and universally associated with neoplasia. Moreover, the gap in survival between African Americans and Caucasians specifically reflects the inability to identify those with occult metastases who are at increased risk for developing recurrent disease.
This study advances an emerging paradigm in colorectal cancer cell detection and eradication, employing GCC as a molecular marker and immunological target. GCC is a protein whose expression is normally restricted to intestinal epithelial cells, but universally expressed by metastatic colorectal tumors. We have clinically validated the detection of occult metastases in lymph nodes by quantifying GCC mRNA (messenger RNA) by reverse transcriptase (RT)-PCR (qRT-PCR). This study revealed that occult metastases were the most powerful independent predictors of survival in pN0 patients. Further, there is a disproportionate burden of occult disease in African American, compared to Caucasian, patients. This new molecular staging platform provides a unique opportunity to identify occult metastases underlying racial disparities in disease recurrence, which could be prevented by tumor-targeted immunotherapy.
In the absence of ideal tumor antigens, immunotherapy has been directed to tissue-specific proteins. Barriers to employing self-antigens include tolerance, which limits anti-tumor immunity, and autoimmunity. The present study advances an emerging paradigm exploiting immunological compartmentalization of mucosally-restricted antigens to generate systemic antitumor immunity without autoimmunity. Asymmetry in immunological cross-talk between compartments, wherein systemic T and B cell responses rarely extend to mucosae, suggest that proteins normally expressed in mucosae, but which are expressed systemically by tumors, may serve as vaccine targets for metastases. Advantages of these cancer mucosa antigens include unique systemic immunoreactivity profiles supporting highly effective durable antitumor immunity in the context of absent immunological cross-talk between compartments restricting autoimmunity. Here, this paradigm will be advanced employing the tumor marker GCC, which induces immune responses that oppose metastatic colorectal cancer in preclinical models, without autoimmunity. This study will define the safety and immunological efficacy of adenoviral GCC vaccine in African American and Caucasian pN0 colon cancer patients with excess recurrence risk reflecting occult lymph node metastases identified by GCC qRT-PCR. This study will be the first step in translating GCC into a vaccine for the secondary prevention of metastases in African American and Caucasian colorectal cancer patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ad5-hGCC-PADRE Vaccine | Experimental | Biological: Ad5-hGCC-PADRE vaccineActive vaccine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male and Female African American or Caucasian subjects older than 18 years of age. Race will be defined by the subject.
- Stage I or stage II (pN0) colon cancer within 3 years of surgery
- Competent immune system, defined by the ability to make a delayed type hypersensitivity (DTH) reaction to at least one of the following: candida, mumps, tetanus or trichophyton
- Adequate renal, liver, and bone marrow functions:
- Serum creatinine ≤ 2.0 mg/dl, Hemoglobin ≥ 10.0 g/dl WBC (white blood cells) ≥ 3,000 /mm3, platelet count ≥ 100,000/mm3, total bilirubin ≤2.0 mg/ml, and albumin ≥ 3.0 g/dl
Key exclusion criteria (14 listed)
- Failure to meet any of the inclusion criteria above
- Rectal cancer
- Prior chemotherapy/radiotherapy/immunotherapy/experimental medications for colon cancer
- Prior splenectomy
- Concurrent use of systemic steroids or immunosuppressive drugs (Note: topical or inhaled aerosol steroid therapies are not contraindicated for participation in the study)
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 |
|---|---|---|
| Ad5-hGCC-PADRE vaccineA single intramuscular dose (100 billion virus particles) of Ad5-hGCC-PADRE vaccine. | Biological | Ad5-hGCC-PADRE Vaccine |
Primary outcome
Adverse events
Time frame: Continuous for 6 months after vaccination.
Quantify treatment-emergent and related acute and sub-acute adverse events, serious adverse events, and Grade 3 and 4 non-laboratory abnormalities for safety assessments during the 6-month period after the injection of Ad5-hGCC-PADRE.
Antibody responses
Time frame: One month following vaccination.
Determine whether Ad5-hGCC-PADRE induces an antibody response to GCC at 1 month following vaccination with Ad5-hGCC-PADRE.
2 secondary outcomes
T cell responses
Time frame: One month following vaccination.
Persistent immunological responses
Time frame: Three and six months after vaccination.
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 2 May 2025.
- Background: PubMed 19224751Waldman SA, Hyslop T, Schulz S, Barkun A, Nielsen K, Haaf J, Bonaccorso C, Li Y, Weinberg DS. Association of GUCY2C expression in lymph nodes with time to recurrence and disease-free survival in pN0 colorectal cancer. JAMA. 2009 Feb 18;301(7):745-52. doi: 10.1001/jama.2009.141.
- Background: PubMed 22057677Snook AE, Magee MS, Marszalowicz GP, Schulz S, Waldman SA. Epitope-targeted cytotoxic T cells mediate lineage-specific antitumor efficacy induced by the cancer mucosa antigen GUCY2C. Cancer Immunol Immunother. 2012 May;61(5):713-23. doi: 10.1007/s00262-011-1133-0. Epub 2011 Nov 6.
- Background: PubMed 19351847Snook AE, Li P, Stafford BJ, Faul EJ, Huang L, Birbe RC, Bombonati A, Schulz S, Schnell MJ, Eisenlohr LC, Waldman SA. Lineage-specific T-cell responses to cancer mucosa antigen oppose systemic metastases without mucosal inflammatory disease. Cancer Res. 2009 Apr 15;69(8):3537-44. doi: 10.1158/0008-5472.CAN-08-3386. Epub 2009 Apr 7.
- Background: PubMed 19956776Snook AE, Huang L, Schulz S, Eisenlohr LC, Waldman SA. Cytokine adjuvanation of therapeutic anti-tumor immunity targeted to cancer mucosa antigens. Clin Transl Sci. 2008 Dec;1(3):263-4. doi: 10.1111/j.1752-8062.2008.00054.x.
- Background: PubMed 20477468Snook AE, Stafford BJ, Eisenlohr LC, Rothstein JL, Waldman SA. Mucosally restricted antigens as novel immunological targets for antitumor therapy. Biomark Med. 2007 Jun;1(1):187-202. doi: 10.2217/17520363.1.1.187.
- Background: PubMed 18577748Snook AE, Stafford BJ, Li P, Tan G, Huang L, Birbe R, Schulz S, Schnell MJ, Thakur M, Rothstein JL, Eisenlohr LC, Waldman SA. Guanylyl cyclase C-induced immunotherapeutic responses opposing tumor metastases without autoimmunity. J Natl Cancer Inst. 2008 Jul 2;100(13):950-61. doi: 10.1093/jnci/djn178. Epub 2008 Jun 24.
- Derived from this study: PubMed 31010434Snook AE, Baybutt TR, Xiang B, Abraham TS, Flickinger JC Jr, Hyslop T, Zhan T, Kraft WK, Sato T, Waldman SA. Split tolerance permits safe Ad5-GUCY2C-PADRE vaccine-induced T-cell responses in colon cancer patients. J Immunother Cancer. 2019 Apr 23;7(1):104. doi: 10.1186/s40425-019-0576-2.
- Derived from this study: PubMed 27716119Myers RE, Wolf T, Shwae P, Hegarty S, Peiper SC, Waldman SA. A survey of physician receptivity to molecular diagnostic testing and readiness to act on results for early-stage colon cancer patients. BMC Cancer. 2016 Oct 3;16(1):766. doi: 10.1186/s12885-016-2812-1.
Related trials for Colon Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
Not yet recruitingPhase 2
Alberta Cancer Exercise Dose in Colorectal Cancer
Cancer, Colorectal Cancer
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.
Scott A Waldman, MD, PhD study director
Thomas Jefferson University
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 Ad5-hGCC-PADRE vaccine in people with Colon Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University at 1 site in United States.
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 11 inclusion and 14 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 2 May 2025. 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 States. 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?
Adverse events (time frame: Continuous for 6 months after vaccination.). The study lists 2 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 NCT01972737, which also lists 8 linked publications.
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 2 May 2025.