Nonneoplastic ConditionPhase 1NCT00722839
Vaccine Therapy in Preventing Cytomegalovirus in Healthy Participants
A Phase 1 study testing PADRE-CMV fusion peptide vaccine, tetanus-CMV fusion peptide vaccine and agatolimod sodium in people with Nonneoplastic Condition, run by City of Hope Medical Center at 1 site in United States.
Trial summary
RATIONALE: Vaccines made from peptides may help the body build an immune response to kill cytomegalovirus. PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy in preventing cytomegalovirus in healthy participants. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Nonneoplastic Condition
- What is being tested?
- PADRE-CMV fusion peptide vaccine, tetanus-CMV fusion peptide vaccine and agatolimod sodium
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2006to Apr 2012
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
DISEASE CHARACTERISTICS:
- Cytomegalovirus (CMV) seropositivity or seronegativity
- HLA A*0201 positive OR positive tetramer-binding using CMV peptide 495-503 with HLA A2 subtypes other than HLA A*0201
- A2-CMV-Tet cells ≤ 10^8/L
PATIENT CHARACTERISTICS:
- Platelet count within 1.5 times upper level of normal (ULN)
- The following blood and chemistry studies must be normal:
- Sodium
- Potassium
- Chloride
- Carbon dioxide
- Glucose
- BUN
- Creatinine
- Uric acid
- WBC
- Hemoglobin
- Hematocrit
- The following studies must be ≤ ULN:
- Albumin
- Alkaline phosphatase
- AST and ALT
- Lactic dehydrogenase
- Total bilirubin
- Hepatitis B virus surface antigen negative
- Hepatitis C virus seronegative
- No diagnosis that is associated with immunodeficiency (e.g., HIV)
- No active infection that requires treatment
- No known cardiac disease including hypertension and/or high cholesterol
- No serious abnormalities by EKG (in participants ≥ 50 years of age)
- Not pregnant
- Negative pregnancy test
- Fertile participants must use effective contraception during study and for 6 weeks after the fourth and last dose of vaccine
- No history of allergic reaction to tetanus toxoid
- No history of any of the following:
- Cancer other than basal cell carcinoma of the skin
- Depression
- Allergic diathesis, as defined by a history of asthma
- Anaphylaxis
- Generalized urticaria or daily use of antihistamines
- Episodic (more than once in the past 3 months) inhalational medications including steroidal agents
- Non-steroidal agents or cromolyn sodium
- Frequent migraines, defined as 3 or more episodes in the past year
- No prior or concurrent infectious condition
PRIOR CONCURRENT THERAPY:
- More than 6 months since prior participation in a CMV immunotherapy trial
- More than 30 days since prior live vaccine
- More than 2 weeks since prior inactivated vaccine
- No concurrent daily medications for chronic or current illness, except for the following:
- Thyroid-replacement therapy
- Estrogen-replacement therapy
- Dietary vitamins and protein supplements
- Any medication, as determined by the principal investigator, that is not known or likely to be immunosuppressive
- No surgery in the past 6 months that required general anesthesia
- Minor procedures (e.g., dental surgery or superficial diagnostics biopsies) allowed
Trial locations and contacts
1 site in 1 country.
United States1 site
City of Hope Comprehensive Cancer Center
Duarte, California, 91010-3000
About this study
Official title: A Phase I Dose Escalation Study of Peptide Vaccines With Activity Against Human Cytomegalovirus
RATIONALE: Vaccines made from peptides may help the body build an immune response to kill cytomegalovirus.
PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy in preventing cytomegalovirus in healthy participants.
Read the detailed description
OBJECTIVES:
Primary
- To establish whether 3 vaccine dose levels of PADRE-CMV and tetanus-CMV fusion peptide vaccines are safe and well tolerated in healthy cytomegalovirus (CMV)-seropositive or -seronegative participants.
- To establish safe dose levels for the PADRE-CMV and tetanus-CMV fusion peptide vaccines in combination with PF 03512676 DNA in these participants.
Secondary
- To provide preliminary evidence of enhanced cellular immunity to CMV at levels of T cells that would support potential feasibility if such cells were to be transferred from the donor to recipients of hematopoietic stem cell transplantation (HSCT) in amounts consistent with protection against disease.
- To determine whether a reduced dose of peptide vaccine can be immunogenic in combination with PF 03512676 DNA.
- To confer CMV-specific cytotoxic T-lymphocyte (CTL) function to CMV-negative participants.
- To determine the duration of immune enhancement of CMV-specific CTL function up to 12 months following immunization of healthy participants.
OUTLINE: This is a dose-escalation study of PADRE-CMV and tetanus-CMV fusion peptide vaccines. Participants are stratified according to cytomegalovirus (CMV) serum status (positive vs negative). Participants are assigned to 1 of 2 groups.
- Group A: Participants receive either PADRE-CMV fusion peptide vaccine or tetanus-CMV fusion peptide vaccine subcutaneously (SC) on days 1, 21, 42, and 63 in the absence of unacceptable toxicity.
- Group B: Participants receive either PADRE-CMV fusion peptide vaccine in CpG 7909 adjuvant SC or tetanus-CMV fusion peptide vaccine in CpG 7909 adjuvant SC on days 1, 21, 42, and 63 in the absence of unacceptable toxicity.
Participants are contacted by telephone every 3-7 days after immunization. Participants also complete a notebook on any health-related event for 14 days after each immunization.
Participants undergo blood sample collection at baseline and periodically during study for immunologic laboratory studies, including flow cytometry, by HLA-A2-CMV-tetramer, CMV-specific intracellular cytokine, CMV-specific CD107 degranulation, lymphoproliferation, and chromium release assays.
After completion of study therapy, participants are followed for up to 1 year.
- Conditions
- Nonneoplastic Condition
- Being tested
- PADRE-CMV fusion peptide vaccine, tetanus-CMV fusion peptide vaccine, agatolimod sodium
- Keywords
- cytomegalovirus infection
- Medical subject headings
- Cytomegalovirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PADRE-CMV fusion peptide vaccineBiological
Given subcutaneously
tetanus-CMV fusion peptide vaccineBiological
Given subcutaneously
agatolimod sodiumDrug
Given subcutaneously
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Participants receive either PADRE-CMV fusion peptide vaccine or tetanus-CMV fusion peptide vaccine subcutaneously (SC) on days 1, 21, 42, and 63 in the absence of unacceptable toxicity. Receives: Biological: PADRE-CMV fusion peptide vaccine; Biological: tetanus-CMV fusion peptide vaccine |
| Group B | Experimental | Participants receive either PADRE-CMV fusion peptide vaccine in CpG 7909 adjuvant SC or tetanus-CMV fusion peptide vaccine in CpG 7909 adjuvant SC on days 1, 21, 42, and 63 in the absence of unacceptable toxicity. Receives: Biological: PADRE-CMV fusion peptide vaccine; Biological: tetanus-CMV fusion peptide vaccine; Drug: agatolimod sodium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful completion of a series of 4 injections (at weeks 0, 3, 6, and 9) without dose-limiting toxicity
Measured: 3 weeks after the final vaccine dose
Maximum tolerated dose of each vaccine with or without adjuvant CpG 7909
Measured: 1 year after the final vaccine dose
Secondary outcomes (1)
Number of CMV-positive and CMV-specific CD8+ T cells/L
Measured: 1 year after final vaccine dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2008 (estimated)
- Study startDec 2006
- Primary completionApr 2012
- Study completionApr 2012
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 Nonneoplastic ConditionStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- John A. Zaia, MD, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00722839
- Sponsor's protocol ID
- City of Hope 03121
- Other IDs
- R01CA077544, P30CA033572, CHNMC-03121, CDR0000599724, NCI-2010-01227
- Status last verified
- Jun 2012
- First submitted
- 25 Jul 2008
- Last updated
- 25 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
La Rosa C, Longmate J, Lacey SF, Kaltcheva T, Sharan R, Marsano D, Kwon P, Drake J, Williams B, Denison S, Broyer S, Couture L, Nakamura R, Dadwal S, Kelsey MI, Krieg AM, Diamond DJ, Zaia JA. Clinical evaluation of safety and immunogenicity of PADRE-cytomegalovirus (CMV) and tetanus-CMV fusion peptide vaccines with or without PF03512676 adjuvant. J Infect Dis. 2012 Apr 15;205(8):1294-304. doi: 10.1093/infdis/jis107. Epub 2012 Mar 7.
PubMed 22402037
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Dose Escalation Study of Peptide Vaccines With Activity Against Human Cytomegalovirus
- ClinicalTrials.gov ID
- NCT00722839
- Acronym / sponsor ID
- City of Hope 03121
- Conditions
- Nonneoplastic Condition
- Keywords
- cytomegalovirus infection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Dec 2006
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 28 Jul 2008 (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.
RATIONALE: Vaccines made from peptides may help the body build an immune response to kill cytomegalovirus.
PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy in preventing cytomegalovirus in healthy participants.
Detailed description
OBJECTIVES:
Primary
- To establish whether 3 vaccine dose levels of PADRE-CMV and tetanus-CMV fusion peptide vaccines are safe and well tolerated in healthy cytomegalovirus (CMV)-seropositive or -seronegative participants.
- To establish safe dose levels for the PADRE-CMV and tetanus-CMV fusion peptide vaccines in combination with PF 03512676 DNA in these participants.
Secondary
- To provide preliminary evidence of enhanced cellular immunity to CMV at levels of T cells that would support potential feasibility if such cells were to be transferred from the donor to recipients of hematopoietic stem cell transplantation (HSCT) in amounts consistent with protection against disease.
- To determine whether a reduced dose of peptide vaccine can be immunogenic in combination with PF 03512676 DNA.
- To confer CMV-specific cytotoxic T-lymphocyte (CTL) function to CMV-negative participants.
- To determine the duration of immune enhancement of CMV-specific CTL function up to 12 months following immunization of healthy participants.
OUTLINE: This is a dose-escalation study of PADRE-CMV and tetanus-CMV fusion peptide vaccines. Participants are stratified according to cytomegalovirus (CMV) serum status (positive vs negative). Participants are assigned to 1 of 2 groups.
- Group A: Participants receive either PADRE-CMV fusion peptide vaccine or tetanus-CMV fusion peptide vaccine subcutaneously (SC) on days 1, 21, 42, and 63 in the absence of unacceptable toxicity.
- Group B: Participants receive either PADRE-CMV fusion peptide vaccine in CpG 7909 adjuvant SC or tetanus-CMV fusion peptide vaccine in CpG 7909 adjuvant SC on days 1, 21, 42, and 63 in the absence of unacceptable toxicity.
Participants are contacted by telephone every 3-7 days after immunization. Participants also complete a notebook on any health-related event for 14 days after each immunization.
Participants undergo blood sample collection at baseline and periodically during study for immunologic laboratory studies, including flow cytometry, by HLA-A2-CMV-tetramer, CMV-specific intracellular cytokine, CMV-specific CD107 degranulation, lymphoproliferation, and chromium release assays.
After completion of study therapy, participants are followed for up to 1 year.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Biological: PADRE-CMV fusion peptide vaccine, Biological: tetanus-CMV fusion peptide vaccineParticipants receive either PADRE-CMV fusion peptide vaccine or tetanus-CMV fusion peptide vaccine subcutaneously (SC) on days 1, 21, 42, and 63 in the absence of unacceptable toxicity. |
| Group B | Experimental | Biological: PADRE-CMV fusion peptide vaccine, Biological: tetanus-CMV fusion peptide vaccine, Drug: agatolimod sodiumParticipants receive either PADRE-CMV fusion peptide vaccine in CpG 7909 adjuvant SC or tetanus-CMV fusion peptide vaccine in CpG 7909 adjuvant SC on days 1, 21, 42, and 63 in the absence of unacceptable toxicity. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
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 |
|---|---|---|
| PADRE-CMV fusion peptide vaccineGiven subcutaneously | Biological | Group A, Group B |
| tetanus-CMV fusion peptide vaccineGiven subcutaneously | Biological | Group A, Group B |
| agatolimod sodiumGiven subcutaneously | Drug | Group B |
Primary outcome
Successful completion of a series of 4 injections (at weeks 0, 3, 6, and 9) without dose-limiting toxicity
Time frame: 3 weeks after the final vaccine dose
Maximum tolerated dose of each vaccine with or without adjuvant CpG 7909
Time frame: 1 year after the final vaccine dose
1 secondary outcome
Number of CMV-positive and CMV-specific CD8+ T cells/L
Time frame: 1 year after final vaccine dose
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 25 Jun 2012.
- Derived from this study: PubMed 22402037La Rosa C, Longmate J, Lacey SF, Kaltcheva T, Sharan R, Marsano D, Kwon P, Drake J, Williams B, Denison S, Broyer S, Couture L, Nakamura R, Dadwal S, Kelsey MI, Krieg AM, Diamond DJ, Zaia JA. Clinical evaluation of safety and immunogenicity of PADRE-cytomegalovirus (CMV) and tetanus-CMV fusion peptide vaccines with or without PF03512676 adjuvant. J Infect Dis. 2012 Apr 15;205(8):1294-304. doi: 10.1093/infdis/jis107. Epub 2012 Mar 7.
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 A. Zaia, MD principal investigator
City of Hope Medical Center
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 PADRE-CMV fusion peptide vaccine, tetanus-CMV fusion peptide vaccine and agatolimod sodium in people with Nonneoplastic Condition, run by City of Hope Medical Center 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?
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 25 Jun 2012. 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?
Successful completion of a series of 4 injections (at weeks 0, 3, 6, and 9) without dose-limiting toxicity (time frame: 3 weeks after the final vaccine dose). 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 NCT00722839, 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 25 Jun 2012.