HER2 Vaccine for Breast Cancer

Overseen By Niraj Shah

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Pravin T.P Kaumaya

Must be taking: HER2 targeted therapy

Must not be taking: CDK4/6 inhibitors, Corticosteroids

Disqualifiers: Active malignancy, Autoimmune diseases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 9 weeks

36 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new vaccine designed to help the immune system fight breast cancer, specifically targeting HER2-positive breast cancer. HER2 is a protein that can cause cancer to grow more aggressively. The vaccine is administered as a shot in the muscle every three weeks, with a booster after six months. Suitable participants have HER2-positive breast cancer and have received HER2-targeted therapy in the past six months. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new vaccine.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you cannot participate if you require corticosteroids or other immunosuppressive drugs, or if you are receiving or planning to receive adjuvant CDK4/6 inhibitor therapy.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

A previous study found the HER2 vaccine to be safe. Most patients who received the vaccine remained alive and disease-free after five years. Research shows that this vaccine is safe and might help prevent resistance to treatment. Another study confirmed the vaccine's safety and suggested it might help fight tumors.

Overall, these studies suggest that the HER2 vaccine is generally well-tolerated, with no major safety concerns reported. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for HER2-positive breast cancer, which typically involve targeted therapies like trastuzumab and chemotherapy, the HER2 vaccine is unique because it aims to stimulate the body’s immune system to fight cancer cells directly. This vaccine works by using specific peptides, MVF-HER2 266-296 and MVF HER2 597-626, to trigger an immune response against the HER2 protein, which is overexpressed in certain breast cancer cells. Researchers are excited about this treatment because it has the potential to offer a more personalized and less toxic approach, reducing the need for traditional chemotherapy and its associated side effects. Additionally, the vaccine’s ability to provide long-lasting immunity through boosters could mean a sustained defense against cancer recurrence.

What evidence suggests that the HER2 Vaccine might be an effective treatment for breast cancer?

Research has shown that the HER2 vaccine for breast cancer, which participants in this trial will receive, may help the immune system identify and destroy cancer cells. One study found that patients who received the vaccine had a 100% chance of remaining cancer-free for five years, compared to 89.4% for those who received a placebo. The vaccine, made from specific proteins, has strengthened the immune response. Early results also suggest it might help prevent resistance to treatment. Overall, these findings highlight the potential of the HER2 vaccine in treating breast cancer. ^{2 5 6 7 8}

Who Is on the Research Team?

Pravin Kaumaya, PhD

Principal Investigator

Indiana University

Are You a Good Fit for This Trial?

This trial is for women over 18 with HER2 positive breast cancer who've finished chemo or radiation at least a month ago and had six months of HER2 therapy. They must not be pregnant, have serious autoimmune diseases, active infections needing antibiotics, other cancers, or heart/lung issues. A negative pregnancy test and agreement to use contraception are required.

Inclusion Criteria

Women of childbearing potential must have a negative serum pregnancy test within 14 days of protocol registration and agree to use effective contraception throughout the study and for 6 months after the last study treatment

Ability to provide written informed consent and HIPAA authorization CTO-IUSCC-0864

My breast cancer is confirmed to be HER2 positive.

Exclusion Criteria

Immediate hypersensitivity skin test positive to specific antigens

Active autoimmune diseases including rheumatoid arthritis, systemic lupus erythematosus, scleroderma, polymyositis dermato-myositis, or a vasculitic syndrome

Developed anaphylactic responses to other vaccines

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the investigational HER2 vaccine intramuscularly every 21 days for three doses, with a booster at 6 months

9 weeks

3 visits (in-person) for initial doses, 1 visit (in-person) for booster

Follow-up

Participants are monitored for immune response and safety through ELISA quantification and adverse event assessment

9 weeks

Regular intervals (in-person)

Long-term follow-up

Participants may be monitored for long-term safety and immune response

6 months

What Are the Treatments Tested in This Trial?

Interventions

• HER2 Vaccine

Trial Overview The study is testing an investigational vaccine designed to stimulate the immune system to combat breast cancer in patients with high-risk disease characteristics after standard treatments.

How Is the Trial Designed?

Group I: HER2 Vaccine Arm Experimental Treatment 1 Intervention

MVF-HER2 266-296 and MVF HER2 597-626 peptide vaccines are combined in 1.5 mg doses of each peptide into a 3.0 mg total dose. This is administered intramuscularly in the gluteus maximus once every 21 days for three doses, in alternating sides (i.e. left-\>right-\>left), with a booster administered at 6 months.

Who Is Running the Clinical Trial?

Pravin T.P Kaumaya

Lead Sponsor

Trials

1

Recruited

40+

Published Research Related to This Trial

HER2 is a key target in breast cancer treatment, as it is over-expressed in 20-30% of cases, and therapies using HER2-directed monoclonal antibodies have significantly improved outcomes for patients with these tumors.

While early phase clinical trials have shown promise for HER2 vaccines, late phase trials have not yet produced clinically relevant results, highlighting the need for further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The clinical development of vaccines for HER2+ breast cancer: Current landscape and future perspectives. Costa, RLB., Soliman, H., Czerniecki, BJ.[2017]

A phase I trial involving 22 women with HER2+ breast cancer showed that a degenerate HER2 epitope-based vaccine was well tolerated and successfully induced strong T-cell immunity in 68% to 88% of patients, with 90% generating T cells that recognized HER2 antigens.

The vaccine not only enhanced T-cell responses but also increased HER2-specific antibodies, and the immunity appeared to be sustained for at least 2 years, suggesting potential for improved outcomes when combined with trastuzumab treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rapid Generation of Sustainable HER2-specific T-cell Immunity in Patients with HER2 Breast Cancer using a Degenerate HLA Class II Epitope Vaccine. Knutson, KL., Block, MS., Norton, N., et al.[2021]

The E75 vaccine demonstrated significant effectiveness in improving immune responses and clinical outcomes, such as reduced recurrence rates and increased disease-free survival in breast cancer patients, with minimal side effects reported.

The GP2 vaccine also showed promise in eliciting immune responses, particularly in increasing CD8+ T-cell numbers, but further clinical trials are necessary to establish its efficacy compared to the E75 vaccine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Application of HER2 peptide vaccines in patients with breast cancer: a systematic review and meta-analysis. You, Z., Zhou, W., Weng, J., et al.[2021]

The combination of the HER2-based vaccine dHER2 and lapatinib was found to be safe for patients with HER2-overexpressing metastatic breast cancer, showing no cardiotoxicity and inducing anti-HER2-specific antibodies in all participants (n=12).

Despite a median time to progression of 55 days, the treatment demonstrated promising long-term survival, with a 300-day overall survival rate of 92%, indicating potential effectiveness in patients who are refractory to trastuzumab.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase 1 clinical trial of HER2-specific immunotherapy with concomitant HER2 kinase inhibition [corrected]. Hamilton, E., Blackwell, K., Hobeika, AC., et al.[2023]

The AE37 vaccine, which targets the HER-2/neu protein in breast cancer, has been shown to be safe and effective in generating long-lasting immune responses in patients, regardless of their HER-2/neu expression levels.

Early clinical trials indicate that the AE37 vaccine may help prevent breast cancer recurrence, highlighting its potential as a promising immunotherapy option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

AE37: a novel T-cell-eliciting vaccine for breast cancer. Sears, AK., Perez, SA., Clifton, GT., et al.[2014]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8608270/

Therapeutic vaccines for breast cancer: Has the time finally ... After a 5-year follow up, the DFS rate in 46 HER2 IHC 3+ BC fully vaccinated patients was 100% versus 89.4% in the 50 HER2 IHC 3+ patients who received placebo ...

2. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2025-05515

Chimeric HER2 B-cell Peptide Vaccine Emulsified in ... Vaccines made from MVF-HER2 266-296 and MVF HER2 597-626 peptides may help the body build an effective immune response to kill tumor cells. Montanide ISA 720, ...

3. withpower.com withpower.com/trial/phase-1-breast-cancer-6-2025-a3c9d

HER2 Vaccine for Breast Cancer A phase I trial involving 22 women with HER2+ breast cancer showed that a degenerate HER2 epitope-based vaccine was well tolerated and successfully induced ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7159438/

Phase 1 Immunotherapy Trial with Two Chimeric HER-2 B ... The study vaccine is safe, exhibits anti-tumor activity and shows preliminary indication that peptide vaccination may avoid therapeutic resistance and offer a ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06414733

NCT06414733 | HER-2 B Cell Peptide Vaccine This phase I trial studies the side effects and best dose of vaccine therapy in treating patients with metastatic solid tumors.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06949410

HER2 Vaccine for Locally Advanced Breast Cancer MVF-HER2 266-296 and MVF HER2 597-626 peptide vaccines are combined in 1.5 mg doses of each peptide into a 3.0 mg total dose. This is administered ...

7. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2025-03029

A Combined Vaccine (MVF-HER-2 [597-626] and ... Giving MVF-HER-2 (597-626) and MVF-HER-2 (266-296) may be safe, tolerable, and/or effective in treating patients with metastatic or unresectable breast or ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S0959804921011850

Therapeutic vaccines for breast cancer: Has the time finally ... A phase I clinical trial is investigating safety and the optimal biological dose (OBD) for a combination of two chimeric trastuzumab-like (MVF-HER-2, aa 597–626) ...