Staphylococcal InfectionsPhase 1NCT01447407
Effect of Adjuvant & Route of Administration on Safety & Immunogenicity of NDV-3 Vaccine
A Phase 1 study testing NDV-3 vaccine with alum IM, NDV-3 vaccine without alum IM and NDV-3 vaccine without alum ID in people with Staphylococcal Infections and Yeast Infections, run by NovaDigm Therapeutics, Inc. at 1 site in United States.
Trial summary
This partially-blind, placebo controlled study is a Phase 1b study using an investigational vaccine, NDV-3, directed against Staphylococcus aureus and Candida sp. This study will compare NDV-3 administered with or without alum delivered intramuscularly (IM) at one dose level. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Staphylococcal Infections, Yeast Infections, Candidiasis
- What is being tested?
- NDV-3 vaccine with alum IM, NDV-3 vaccine without alum IM and NDV-3 vaccine without alum ID
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 164 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Dec 2012
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Informed of the nature of the study and have agreed to and are able to read, review, and sign the informed consent document prior to screening. The informed consent document will be written in English, therefore the volunteer must have the ability to read and communicate in English.
- Completed the screening process (as described in this protocol) within 28 days prior to dosing.
- Healthy male and female volunteers 18-50 years of age, inclusive, at the time of dosing.
- No clinically significant deviation from normal as judged by the investigator(s) in the medical history, physical examination (including but may not be limited to an evaluation of the cardiovascular, gastrointestinal, respiratory and central nervous systems), vital sign assessments, 12-lead electrocardiogram (ECG), clinical laboratory assessments, and by general observations.
- Female volunteers must be one of the following:
- of childbearing potential and practicing an acceptable method of birth control as judged by the Investigator(s)
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- naturally postmenopausal (no menses) for at least 1 year and has a documented FSH level ≥ 40 mIU/mL
- surgically postmenopausal (bilateral oophorectomy or hysterectomy)
- sterile (surgically [bilateral tubal ligation] or the Essure® Procedure) Female volunteers that are surgically sterile or surgically postmenopausal must provide documentation of the bilateral tubal ligation, bilateral oophorectomy, or hysterectomy prior to dosing or the volunteer must agree to use a medically acceptable method of birth control. The Essure® Procedure must have been inserted at least 3 months prior with documentation of the Essure® confirmation test prior to Period I dosing. If the procedure was inserted less than 3 months prior to Period I dosing or proper documentation of the confirmation test is not provided, the volunteer must agree to use an additional medically acceptable method of birth control.
Who cannot join
- Reports receiving any investigational drug, investigational vaccine, or investigational device within 30 days prior to dosing.
- Reports any presence or history of a clinically significant disorder involving the cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic, endocrine, or neurologic system(s) or psychiatric disease as determined by the Investigator(s).
- Clinical laboratory test values outside the accepted range.
- When confirmed upon additional testing, demonstrates a reactive screen for hepatitis B surface antigen, hepatitis C antibody, or HIV antibody.
- Demonstrates a positive drug screen for non-prescription drugs.
- Reports a clinically significant illness during the 28 days prior to dosing (as determined by the Investigator[s]).
Show all 20Show fewer
- Reports a history of allergic response(s) to nickel or anaphylaxis (or other serious reactions) to aluminum.
- Reports receiving any live attenuated vaccine including FluMist® within 6 weeks prior to dosing or any licensed inactivated vaccine within 3 weeks prior to dosing.
- Reports the use of any immunosuppressive drugs, including systemic corticosteroids, within 4 weeks prior to dosing.
- Reports the use of any medications or treatments that may alter immune responses to the study vaccine within 3 weeks prior to dosing (eg, cyclosporine, tacrolimus, cytotoxic drugs, immune globulin, Bacillus Calmette-Guerin [BCG], monoclonal antibodies, radiation therapy).
- Reports a history of clinically significant allergies including food or drug allergies or anaphylaxis (or other serious reactions) to vaccines.
- Reports a history of drug or alcohol addiction or abuse within the past year.
- Reports receiving any blood products within 3 months prior to dosing and throughout the study.
- Reports donating blood within 28 days prior to dosing. All subjects will be advised not to donate blood for four weeks after completing the study.
- Reports donating plasma (e.g. plasmapheresis) within 14 days prior to dosing. All subjects will be advised not to donate plasma for four weeks after completing the study.
- Demonstrates, in the opinion of study staff, veins unsuitable for repeated venipuncture (e.g. veins difficult to locate, access, or puncture; veins with a tendency to rupture during or after puncture).
- Pregnant, lactating, breastfeeding, or intends to become pregnant over the course of the study.
- Demonstrates a positive pregnancy screen.
- Reports smoking or using tobacco products or is currently using nicotine products (patches, gums, etc). Thirty (30) days abstinence prior to dosing is required.
- Any other medical and/or social (e.g. uncooperative or non-compliant) reason which, in the opinion of the investigator(s), would prevent participation in the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cetero Research Clinical Site
Fargo, North Dakota, 58104
About this study
Official title: Phase 1b Study to Evaluate the Safety and Immunogenicity of NDV-3 Formulated With or Without Alum (AlOH) and Administered Either Intramuscular (IM) or Intradermally (ID) to Healthy Adults
This partially-blind, placebo controlled study is a Phase 1b study using an investigational vaccine, NDV-3, directed against Staphylococcus aureus and Candida sp. This study will compare NDV-3 administered with or without alum delivered intramuscularly (IM) at one dose level. It will also evaluate a lower dose of NDV-3 without alum delivered intradermally (ID) compared to placebo delivered ID.
Read the detailed description
Preclinical studies in mice have established that several members of the Als family of proteins induce a protective immune response in mice and allow high survival rates following challenge with highly virulent doses of either Candida or S. aureus. Als3 (the antigen in the NDV-3 investigational vaccine) is the most effective member of the Als protein family in protecting mice from challenge with either Candida or S. aureus. The first Phase 1 study enrolled 40 healthy subjects that received placebo (N=10), 1 dose (N=30) or 2 doses (N=19) of the NDV-3 vaccine administered intramuscularly (IM). The vaccine was well tolerated and highly immunogenic. This study will evaluate the safety, tolerability and immunogenicity of one dose of NDV-3 vaccine formulated with and without alum given IM and also a lower dose without alum given intradermally (ID). Subjects will have follow-up visits to assess the safety tolerability and immune responses at selected time points up to 90 days post-vaccination.
- Conditions
- Staphylococcal Infections, Yeast Infections, Candidiasis
- Being tested
- NDV-3 vaccine with alum IM, NDV-3 vaccine without alum IM, Placebo with alum IM, NDV-3 vaccine without alum ID
- Keywords
- Staphylococcal infections, Yeast infections, Candidiasis
- Medical subject headings
- Staphylococcal Infections, Candidiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NDV-3 vaccine with alum IMBiological
One dose administered IM
NDV-3 vaccine without alum IMBiological
One dose administered IM
Placebo with alum IMBiological
One dose administered ID
NDV-3 vaccine without alum IDBiological
One dose administered ID
| Study group | Role | What they receive |
|---|---|---|
| NDV-3 vaccine with alum IM | Active comparator | 300 ug Als3 and 0.5 mg Al as alum in PBS per dose, one dose administered IM Receives: Biological: NDV-3 vaccine with alum IM |
| NDV-3 vaccine without alum IM | Active comparator | 300 ug Als3 in PBS per dose, one dose administered IM Receives: Biological: NDV-3 vaccine without alum IM |
| Placebo IM | Placebo comparator | 0.5 mg Al as alum in PBS per dose, one dose administered IM Receives: Biological: Placebo with alum IM |
| NDV-3 vaccine without alum ID | Active comparator | 30 ug Als3 in PBS per dose, one dose administered ID Receives: Biological: NDV-3 vaccine without alum ID |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment Emergent Adverse Events
The primary objective of this study is to assess the safety of a single dose of NDV-3 vaccine, administered either IM with or without alum adjuvant at one dose level or ID at a lower dose level, compared to placebo. Clinical evaluations will be assessed on each subject at selected time points up to 90 days post-vaccination.
Measured: Up to 90 days post-vaccination
Secondary outcomes (6)
Immunogenicity - Serum Anti-Als3 IgG
A secondary objective is to compare the serum IgG immune response between the 2 dose levels, routes of administration, and effects of alum adjuvant, at selected time points up to 90 days post-vaccination. Serum IgG will be evaluated by ELISA on serial-diluted samples, resulting in titer values of reciprocal dilution at which the ELISA readout is three times greater than the assay background value.
Measured: Baseline, Day 7, Day 14, Day 28, Day 90/Exit
Immunogenicity - Serum Anti-Als3 IgA1
A secondary objective is to compare the serum IgA1 immune response between the 2 dose levels, routes of administration, and effects of alum adjuvant, at selected time points up to 90 days post-vaccination. Serum IgA1 will be evaluated by ELISA on serial-diluted samples, resulting in titer values of reciprocal dilution at which the ELISA readout is three times greater than the assay background value.
Measured: Baseline, Day 7, Day 14, Day 28, Day 90/Exit
Immunogenicity - Cervicovaginal Wash Anti-Als3 IgG
A secondary objective is to compare the cervicovaginal wash IgG immune response between the 2 dose levels, routes of administration, and effects of alum adjuvant, at selected time points up to 90 days post-vaccination. Cervicovaginal wash IgG will be evaluated by ELISA on serial-diluted samples, resulting in titer values of reciprocal dilution at which the ELISA readout is three times greater than the assay background value.
Measured: Baseline, Day 7, Day 14, Day 28, Day 90/Exit
Immunogenicity - Cervicovaginal Wash Anti-Als3 IgA1
A secondary objective is to compare the cervicovaginal wash IgA1 immune response between the 2 dose levels, routes of administration, and effects of alum adjuvant, at selected time points up to 90 days post-vaccination. Cervicovaginal wash IgA1 will be evaluated by ELISA on serial-diluted samples, resulting in titer values of reciprocal dilution at which the ELISA readout is three times greater than the assay background value.
Measured: Baseline, Day 7, Day 14, Day 28, Day 90/Exit
Immunogenicity - Number of Participants Positive for Peripheral Blood Mononuclear Cells (PBMCs) Producing Als3-specific Interferon-gamma (IFN-g)
A secondary objective is to compare the cellular immune response for Als3-specific production of IFN-g from PBMCs between the 2 dose levels, routes of administration, and effects of alum adjuvant, at selected time points up to 90 days post-vaccination. The IFN-g cellular immune responses will be evaluated by ELISpot using approximately 200,000 PBMCs per well. A positive response was defined as a sample with greater than 20 spot forming units per 10^6 PBMCs.
Measured: Baseline, Day 7, Day 14, Day 28, Day 90/Exit
Immunogenicity - Number of Participants Positive for Peripheral Blood Mononuclear Cells (PBMCs) Producing Als3-specific Interleukin-17A (IL-17A)
A secondary objective is to compare the cellular immune response for Als3-specific production of IL-17A from PBMCs between the 2 dose levels, routes of administration, and effects of alum adjuvant, at selected time points up to 90 days post-vaccination. The IL-17A cellular immune responses will be evaluated by ELISpot using approximately 200,000 PBMCs per well. A positive response was defined as a sample with greater than 20 spot forming units per 10^6 PBMCs.
Measured: Baseline, Day 7, Day 14, Day 28, Day 90/Exit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2011 (estimated)
- Study startSep 2011
- Primary completionMar 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Staphylococcal 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
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- NovaDigm Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01447407
- Sponsor's protocol ID
- NDV3-002
- Status last verified
- Feb 2020
- First submitted
- 3 Oct 2011
- Last updated
- 4 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Schmidt CS, White CJ, Ibrahim AS, Filler SG, Fu Y, Yeaman MR, Edwards JE Jr, Hennessey JP Jr. NDV-3, a recombinant alum-adjuvanted vaccine for Candida and Staphylococcus aureus, is safe and immunogenic in healthy adults. Vaccine. 2012 Dec 14;30(52):7594-600. doi: 10.1016/j.vaccine.2012.10.038. Epub 2012 Oct 22.
PubMed 23099329
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1b Study to Evaluate the Safety and Immunogenicity of NDV-3 Formulated With or Without Alum (AlOH) and Administered Either Intramuscular (IM) or Intradermally (ID) to Healthy Adults
- ClinicalTrials.gov ID
- NCT01447407
- Acronym / sponsor ID
- NDV3-002
- Conditions
- Staphylococcal Infections, Yeast Infections, Candidiasis
- Keywords
- Staphylococcal infections, Yeast infections, Candidiasis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- NovaDigm Therapeutics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- United States Department of Defense
- Study start
- Sep 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 6 Oct 2011 (estimated)
- Results
- Posted 4 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This partially-blind, placebo controlled study is a Phase 1b study using an investigational vaccine, NDV-3, directed against Staphylococcus aureus and Candida sp. This study will compare NDV-3 administered with or without alum delivered intramuscularly (IM) at one dose level. It will also evaluate a lower dose of NDV-3 without alum delivered intradermally (ID) compared to placebo delivered ID.
Detailed description
Preclinical studies in mice have established that several members of the Als family of proteins induce a protective immune response in mice and allow high survival rates following challenge with highly virulent doses of either Candida or S. aureus. Als3 (the antigen in the NDV-3 investigational vaccine) is the most effective member of the Als protein family in protecting mice from challenge with either Candida or S. aureus. The first Phase 1 study enrolled 40 healthy subjects that received placebo (N=10), 1 dose (N=30) or 2 doses (N=19) of the NDV-3 vaccine administered intramuscularly (IM). The vaccine was well tolerated and highly immunogenic. This study will evaluate the safety, tolerability and immunogenicity of one dose of NDV-3 vaccine formulated with and without alum given IM and also a lower dose without alum given intradermally (ID). Subjects will have follow-up visits to assess the safety tolerability and immune responses at selected time points up to 90 days post-vaccination.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| NDV-3 vaccine with alum IM | Active comparator | Biological: NDV-3 vaccine with alum IM300 ug Als3 and 0.5 mg Al as alum in PBS per dose, one dose administered IM |
| NDV-3 vaccine without alum IM | Active comparator | Biological: NDV-3 vaccine without alum IM300 ug Als3 in PBS per dose, one dose administered IM |
| Placebo IM | Placebo comparator | Biological: Placebo with alum IM0.5 mg Al as alum in PBS per dose, one dose administered IM |
| NDV-3 vaccine without alum ID | Active comparator | Biological: NDV-3 vaccine without alum ID30 ug Als3 in PBS per dose, one dose administered ID |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Informed of the nature of the study and have agreed to and are able to read, review, and sign the informed consent document prior to screening. The informed consent document will be written in English, therefore the volunteer must have the ability to read and communicate in English.
- Completed the screening process (as described in this protocol) within 28 days prior to dosing.
- Healthy male and female volunteers 18-50 years of age, inclusive, at the time of dosing.
- No clinically significant deviation from normal as judged by the investigator(s) in the medical history, physical examination (including but may not be limited to an evaluation of the cardiovascular, gastrointestinal, respiratory and central nervous systems), vital sign assessments, 12-lead electrocardiogram (ECG), clinical laboratory assessments, and by general observations.
- Female volunteers must be one of the following:
Key exclusion criteria (20 listed)
- Reports receiving any investigational drug, investigational vaccine, or investigational device within 30 days prior to dosing.
- Reports any presence or history of a clinically significant disorder involving the cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic, endocrine, or neurologic system(s) or psychiatric disease as determined by the Investigator(s).
- Clinical laboratory test values outside the accepted range.
- When confirmed upon additional testing, demonstrates a reactive screen for hepatitis B surface antigen, hepatitis C antibody, or HIV antibody.
- Demonstrates a positive drug screen for non-prescription drugs.
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 |
|---|---|---|
| NDV-3 vaccine with alum IMOne dose administered IM | Biological | NDV-3 vaccine with alum IM |
| NDV-3 vaccine without alum IMOne dose administered IM | Biological | NDV-3 vaccine without alum IM |
| Placebo with alum IMOne dose administered ID | Biological | Placebo IM |
| NDV-3 vaccine without alum IDOne dose administered ID | Biological | NDV-3 vaccine without alum ID |
Primary outcome
Number of Participants With Treatment Emergent Adverse Events
Time frame: Up to 90 days post-vaccination
The primary objective of this study is to assess the safety of a single dose of NDV-3 vaccine, administered either IM with or without alum adjuvant at one dose level or ID at a lower dose level, compared to placebo. Clinical evaluations will be assessed on each subject at selected time points up to 90 days post-vaccination.
6 secondary outcomes
Immunogenicity - Serum Anti-Als3 IgG
Time frame: Baseline, Day 7, Day 14, Day 28, Day 90/Exit
Immunogenicity - Serum Anti-Als3 IgA1
Time frame: Baseline, Day 7, Day 14, Day 28, Day 90/Exit
Immunogenicity - Cervicovaginal Wash Anti-Als3 IgG
Time frame: Baseline, Day 7, Day 14, Day 28, Day 90/Exit
Immunogenicity - Cervicovaginal Wash Anti-Als3 IgA1
Time frame: Baseline, Day 7, Day 14, Day 28, Day 90/Exit
Immunogenicity - Number of Participants Positive for Peripheral Blood Mononuclear Cells (PBMCs) Producing Als3-specific Interferon-gamma (IFN-g)
Time frame: Baseline, Day 7, Day 14, Day 28, Day 90/Exit
Immunogenicity - Number of Participants Positive for Peripheral Blood Mononuclear Cells (PBMCs) Producing Als3-specific Interleukin-17A (IL-17A)
Time frame: Baseline, Day 7, Day 14, Day 28, Day 90/Exit
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23099329Schmidt CS, White CJ, Ibrahim AS, Filler SG, Fu Y, Yeaman MR, Edwards JE Jr, Hennessey JP Jr. NDV-3, a recombinant alum-adjuvanted vaccine for Candida and Staphylococcus aureus, is safe and immunogenic in healthy adults. Vaccine. 2012 Dec 14;30(52):7594-600. doi: 10.1016/j.vaccine.2012.10.038. Epub 2012 Oct 22.
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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 NDV-3 vaccine with alum IM, NDV-3 vaccine without alum IM and NDV-3 vaccine without alum ID in people with Staphylococcal Infections and Yeast Infections, run by NovaDigm Therapeutics, Inc. 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 9 inclusion and 20 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 4 Mar 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 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. 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?
Yes. Results are posted in the registry (first posted 4 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Treatment Emergent Adverse Events (time frame: Up to 90 days post-vaccination). 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 NCT01447407, 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 4 Mar 2020.