What literature supports high-dose influenza vaccine in post-hematopoietic stem cell transplant? Specifically, in pediatric patients. What does it say about subsequent influenza seasons beyond the first season post-transplant?

Comment by InpharmD Researcher

Current guidelines recommend annual influenza vaccination after hematopoietic stem cell transplantation (HSCT), although pediatric HSCT-specific guidance regarding high-dose vaccination, number of doses, and subsequent influenza seasons is limited. Pediatric evidence is largely derived from a single randomized trial and subsequent analyses of that cohort (see Tables 1 and 2); findings suggest greater immunogenicity with high-dose inactivated influenza vaccine (HD-IIV) for some influenza antigens compared with standard-dose vaccination. Among participants who reenrolled for a second consecutive influenza season, 1 dose of either high- or standard-dose vaccine met prespecified immunogenicity criteria, suggesting that 1 dose may be sufficient in the subsequent season. While these findings provide some evidence to inform influenza vaccination after pediatric HSCT, caution may be warranted given the limited evidence regarding optimal vaccine dose and dosing strategy, particularly across subsequent seasons.

influenza flu vaccine HSCT stem cell transplant pediatric

Background

The Centers for Disease Control and Prevention (CDC) recommends annual, age-appropriate inactivated or recombinant influenza vaccination for immunocompromised patients, noting that immune responses may be reduced with post-transplant regimens. However, the CDC does not specifically recommend standard- versus high-dose vaccination for pediatric immunocompromised patients, address pediatric hematopoietic stem cell transplant (HSCT) recipients, or provide guidance on high-dose vaccination in subsequent post-transplant seasons. [1]

The latest National Comprehensive Cancer Network (NCCN) guidelines on the prevention and treatment of cancer-related infections (Version 1.2026) recommend annual injectable influenza vaccination beginning 3-6 months after hematopoietic cell transplant, with consideration of a high-dose vaccine or re-dose. Patients with hematologic or solid tumor malignancy should receive an inactivated or recombinant influenza vaccine. However, the guideline does not provide pediatric-specific recommendations for high-dose vaccination or specific guidance on high-dose use in subsequent post-transplant seasons. [2]

The 2024 American Society of Clinical Oncology (ASCO) guideline on vaccination of adults with cancer recommends high-dose inactivated influenza vaccine (IIV) for adult HSCT recipients regardless of age, based on improved immunogenicity compared with standard-dose IIV. Influenza vaccination is generally administered 6 months after HSCT but may be given 3-6 months after autologous or allogeneic HSCT during periods of high community transmission. A randomized trial in pediatric HSCT recipients aged 3-17 years found 2 doses of high-dose IIV were safe and demonstrated superior immunogenicity for influenza A antigens compared with standard-dose IIV (Table 1). However, the guideline is specifically intended for adults with cancer, does not provide a pediatric-specific high-dose recommendation, and does not address high-dose vaccination in subsequent influenza seasons after the initial post-transplant season. They also do not make a recommendation of 2 doses versus a single dose. [3]

The 2025 Infectious Diseases Society of America (IDSA) guidelines on the use of vaccines for the prevention of seasonal COVID-19, influenza, and RSV Infections in immunocompromised patients note that high-dose or adjuvanted influenza vaccines produce more robust immune responses, which may be particularly important in immunocompromised patients. Similarly, this guidance does not specifically address pediatric HSCT recipients or provide recommendations for high-dose vaccination in subsequent post-transplant influenza seasons. [4]

A 2026 American Academy of Pediatrics (AAP) review article discussing influenza vaccination in immunocompromised children highlights a phase 2 multicenter randomized controlled trial in pediatric allogeneic HCT recipients (Pediatric HCT Flu Study) in which 2 doses of high-dose inactivated influenza vaccine were more immunogenic than 2 doses of standard-dose vaccine when administered 3-35 months after HCT, with similar safety (see Table 1). Based on these data, the authors suggest that clinicians may consider 2 doses of HD-IIV in HCT recipients ≥3 years of age during the first post-transplant influenza season; however, HD-IIV is not currently approved for pediatric use. The authors also note that a subset of patients from the phase 2 study reenrolled the following year, with results suggesting that 1 dose of either high- or standard-dose vaccine may be sufficient in the subsequent season if 2 HD-IIV doses were received during the first post-transplant vaccine season (see Table 2). The review further notes that these data are based on small studies and that more comprehensive clinical studies of alternative influenza vaccine formulations and dosing strategies in pediatric patients are needed. [5]

A 2025 systematic review and meta-analysis evaluated high-dose versus standard-dose influenza vaccination after HCT across 4 randomized controlled trials (n= 402), including both adult and pediatric recipients. Only 1 of the 4 included randomized controlled trials specifically evaluated pediatric HCT recipients, representing the same phase 2 trial briefly described in the Kao et al., review; this trial included children with a mean age of approximately 11 years who were vaccinated either 3-5 months or 6-35 months after HCT (see Table 1). The overall findings from the meta-analysis suggested that high-dose vaccination did not significantly improve hemagglutination inhibition titers ≥1:40 after the first dose, second dose, or at 6 months, although the >4-fold antibody response favored high-dose vaccination after the second dose (odds ratio [OR] 1.29; 95% CI 1.00 to 1.66; p= 0.05). There was no significant difference in confirmed influenza (OR 1.61; 95% CI 0.67 to 3.87), while local adverse effects were more frequent with high-dose vaccination (42.3% vs. 16.8%); systemic adverse effects did not significantly differ. The analysis did not specifically evaluate high-dose vaccination strategies in subsequent post-transplant influenza seasons, although it references the same second-season study described above, in which a subset of pediatric HCT recipients from the original trial were vaccinated during a second consecutive influenza season (see Table 2). [6]

Background References: [1] Centers For Disease Control and Prevention. Interim Clinical Considerations for the Use of Seasonal Influenza Vaccines in the United States. Published September 1, 2026. Accessed October 1, 2026. https://www.cdc.gov/flu/hcp/vax-summary/seasonal-influenza-vaccines.html
[2] National Comprehensive Cancer Network. Prevention and Treatment of Cancer-Related Infections. Version 1.2026. Published March 11, 2026. Accessed October 1, 2026. https://www.nccn.org/professionals/physician_gls/pdf/infections.pdf
[3] Kamboj M, Bohlke K, Baptiste DM, et al. Vaccination of Adults With Cancer: ASCO Guideline. J Clin Oncol. 2024;42(14):1699-1721. doi:10.1200/JCO.24.00032
[4] Nellore A, Goepfert P, Tan CS, et al. IDSA 2025 Guidelines on the Use of Vaccines for the Prevention of Seasonal COVID-19, Influenza, and RSV Infections in Immunocompromised Patients. Clin Infect Dis. 2026;82(Suppl 3):i105-i110. doi:10.1093/cid/ciag114
[5] Kao CM, Bahakel H, Heald-Sargent TA, et al. Influenza, COVID-19, and RSV vaccinations for immunocompromised children and household contacts. Pediatrics. 2026;158(2):e2026075971. doi:10.1542/peds.2026-075971
[6] Vidya AP, Wijaya NJ, Gathmir DZP, Kornel NAK, Farhan M, Sianipar IR. Safety and efficacy of high-dose versus standard-dose influenza vaccines in hematopoietic stem cell transplant recipients: A meta-analysis of randomized controlled trials. Transpl Immunol. 2025;92:102270. doi:10.1016/j.trim.2025.102270
Literature Review

A search of the published medical literature revealed 2 studies investigating the researchable question:

What literature supports high-dose influenza vaccine in post-hematopoietic stem cell transplant? Specifically, in pediatric patients. What does it say about subsequent influenza seasons beyond the first season post-transplant?

Level of evidence

A - Multiple high-quality studies with consistent results  Read more→



Please see Tables 1-2 for your response.


 

The Durability of Antibody Responses of Two Doses of High-Dose Relative to Two Doses of Standard-Dose Inactivated Influenza Vaccine in Pediatric Hematopoietic Cell Transplant Recipients: A Multi-Center Randomized Controlled Trial

Design

Phase II, multi-center, double-blinded, randomized controlled trial (Pediatric HCT Flu Study)

N= 170

Objective

To evaluate the durability of antibody responses and the immunogenicity of two doses of high-dose trivalent influenza vaccine (HD-IIV3) compared to two doses of standard-dose quadrivalent influenza vaccine (SD-IIV4) in pediatric hematopoietic cell transplant recipients

Study Groups

HD-IIV3 (n= 85)

SD-IIV4 (n= 85)

Inclusion Criteria

Children aged 3–17 years, 3–35 months post-allogeneic HCT, with stable graft-versus-host disease (GVHD) and therapy for at least 4 weeks prior to enrollment

Exclusion Criteria

Influenza vaccine or egg hypersensitivity, Guillain-Barré syndrome, post-transplant disease relapse, prior current-season influenza vaccination or influenza infection, pregnancy, non-allogeneic transplant, active HIV/hepatitis B/hepatitis C infection, severe latex hypersensitivity, recent stem cell boost/donor lymphocyte infusion, recent intravenous/subcutaneous immunoglobulin

Methods

Participants were randomized to receive either 2 doses of HD-IIV3 or SD-IIV4 (quadrivalent high-dose formulation was unavailable at the time of study), administered 28-42 days apart. Hemagglutination inhibition (HAI) titers were measured at baseline, 28-42 days following each dose, and 138-222 days after the second dose. Linear mixed effects models were used to estimate adjusted geometric mean HAI titer ratios.

Duration

3 influenza seasons (2016-2019)

Outcome Measures

Adjusted geometric mean hemagglutination inhibition titer ratios (aGMR) to influenza antigens

Baseline Characteristics  

All (N= 170)

Control (SD-IIV3; n= 85) Experimental (HD-IIV4; n= 85)

Age at enrollment, years

10.8 ± 4.3 10.6 ± 4.4 11.0 ± 4.2

Male

94 (55.3%) 49 (57.7%) 45 (52.9%)

Race

White

Black/African American

 

117 (68.8%)

31 (18.2%)

 

62 (72.9%)

12 (14.1%)

 

55 (64.7%)

19 (22.4%)

Time from transplant to enrollment, months (IQR)

7.8 (4.3-13.4) 9.2 (5.0-15.9) 6.0 (4.1-12.2)

Related donor

79 (46.5%) 40 (47.1%) 39 (45.9%)
Results  

Geometric Mean Fold-rises

aGMR (95% CI)
SD-IIV4 (n= 85)

HD-IIV3 (n= 85)

A/H1N1 Visit 3 2.97 (1.92–4.58)

4.02 (2.63–6.13)

1.65 (1.06–2.57)
A/H3N2 Visit 3 2.79 (1.78–4.37)

4.82 (2.90–8.01)

2.11 (1.32–3.38)
B/Victoria Visit 3 4.16 (2.65–6.53)

4.84 (3.06–7.67)

1.46 (0.93–2.31)

Two doses of HD-IIV3 produced significantly higher antibody titers than SD-IIV4 after the second dose for A/H1N1 and A/H3N2, although these differences were no longer significant approximately 6 months after the second dose.

The benefit of HD-IIV3 was more apparent among patients vaccinated 6-35 months after HCT, with significantly higher post-second-dose titers for A/H1N1, A/H3N2, and B/Victoria, whereas significant differences were not observed among those vaccinated 3-5 months after HCT.

Adverse Events

Laboratory-confirmed influenza occurred in 13 patients (7.6%), including 7 in the HD-IIV3 group and 6 in the SD-IIV4 group; 4 of the 7 HD-IIV3 cases were B/Yamagata, which was not included in HD-IIV3.

Other adverse events were not reported.

Study Author Conclusions

Two doses of HD-IIV3 were more immunogenic than SD-IIV4, especially when administered ≥6 months post-HCT. Both groups maintained higher titers compared to baseline throughout the season.

Critique

The study's strengths include its multi-center design and the use of a randomized controlled trial to assess immunogenicity. However, limitations include the lack of power to determine the efficacy of HD-IIV3 in preventing influenza infection and the absence of B/Yamagata in the HD-IIV3 formulation, which may affect generalizability. Additionally, the study did not provide detailed adverse event data.

 

Table 1 References:
[7] Schuster JE, Hamdan L, Dulek DE, et al. The Durability of Antibody Responses of Two Doses of High-Dose Relative to Two Doses of Standard-Dose Inactivated Influenza Vaccine in Pediatric Hematopoietic Cell Transplant Recipients: A Multi-Center Randomized Controlled Trial. Clin Infect Dis. 2024;78(1):217-226. doi:10.1093/cid/ciad534
[8] ClinicalTrials.gov. High-dose influenza vaccine for children with cancer or blood disorders. ClinicalTrials.gov identifier: NCT02860039. Updated October 22, 2024. Accessed October 1, 2026. https://clinicaltrials.gov/study/NCT02860039

 

Immunogenicity and Reactogenicity of High- or Standard-Dose Influenza Vaccine in a Second Consecutive Influenza Season

Design

Phase II, multicenter, double-blind, randomized, active-controlled, clinical trial

N= 65

Objective

To evaluate the safety and immunogenicity of high-dose trivalent influenza vaccine (HD-IIV3) or standard-dose quadrivalent influenza vaccine (SD-IIV4) administered within 2 consecutive influenza seasons in pediatric hematopoietic cell transplant (HCT) recipients

Study Groups

SD-IIV4 (n= 33)

HD-IIV3 (n= 32)

Inclusion Criteria

Children and adolescents 3 to 17 years of age who had received an allogeneic HCT 3 to 35 months preceding enrollment; participants with stable graft-vs-host disease (GVHD) therapy for at least 4 weeks prior to enrollment

Exclusion Criteria

Participants with evidence of hematologic malignancy or disease relapse posttransplant

Methods

This study was a second-season substudy of the previously tabled phase 2, multicenter, double-blind randomized controlled Pediatric HCT Flu Study (see Table 1; Schuster et al., 2024), which compared 2 doses of HD-IIV3 with SD-IIV4 (quadrivalent high-dose vaccine was unavailable at the time of study) in children and adolescents 3-17 years of age who were 3-35 months after allogeneic HCT.

Participants who completed both assigned doses during the first season could reenroll the following influenza season and remained assigned to their original vaccine regimen; the substudy was conducted across the same 9 US sites over 3 influenza seasons. In both years, participants received two 0.5-mL doses approximately 4 weeks apart; SD-IIV4 contained 15 mcg of antigen per strain, whereas HD-IIV3 contained 60 mcg per strain and did not contain B/Yamagata.

Duration

2017–2018, 2018–2019, and 2019–2020 influenza seasons

Outcome Measures

Immunogenicity measured by geometric mean fold rise in hemagglutinin inhibition titer

Baseline Characteristics

Of the 170 pediatric HCT recipients randomized in the primary study, 65 (38%) reenrolled for a second consecutive influenza season, including 33 who received SD-IIV4 and 32 who received HD-IIV3. Participants had a mean age of 12.4 years with SD-IIV4 and 12.0 years with HD-IIV3 in year 2 and were a median of 22.5 and 19.5 months post-HCT, respectively; nearly all were 12 to <36 months post-HCT.

Overall, 47.7% were male, 63.1% were White, 26.2% were Black, and 18.5% were Hispanic; malignancy was the most common indication for HCT, severe aplastic anemia was the most common nonmalignant indication, and bone marrow was the predominant stem cell source (67.7%).

Demographic and clinical characteristics were similar between vaccine groups and between participants who reenrolled and those who participated only in the primary study.

Results

In the second influenza season, a single dose of either HD-IIV3 or SD-IIV4 produced significant increases in antibody titers, and geometric mean titers (GMTs) after 1 dose in year 2 were significantly higher than those achieved after 2 doses of the same vaccine formulation in year 1 for all antigens except A/H3N2 with HD-IIV3. After 2 years of 2 doses, GMTs were also significantly higher than after 2 doses in year 1. Even though HD-IIV3 produced numerically higher GMTs than SD-IIV4 for A/H1N1, A/H3N2, and B/Victoria, between-group differences were not statistically significant.

Importantly, prespecified immunogenicity criteria were met after a single dose of either vaccine formulation in year 2, supporting that a single dose may provide adequate immunogenicity during the subsequent season in children previously vaccinated after HCT. Safety was generally similar between groups: systemic reactions after the second year-2 dose occurred in 50.0% with HD-IIV3 and 51.5% with SD-IIV4 (p= 0.90), and severe injection-site reactions occurred in 18.8% and 18.2%, respectively (p= 0.95); laboratory-confirmed influenza occurred in 2 HD-IIV3 and 6 SD-IIV4 recipients during year 2.

Adverse Events

The frequencies of systemic reactions were comparable between HD-IIV3 and SD-IIV4 groups. Injection site reactions were mostly mild or moderate, with no significant difference in severe reactions between groups.

Study Author Conclusions

A single dose of HD-IIV3 or SD-IIV4 in the second year was more immunogenic than 2 doses in the first year. Reactogenicity was comparable between groups, suggesting that one dose may be sufficient after a 2-dose schedule in the prior year post-HCT.

Critique

The study provides valuable insights into the immunogenicity and safety of influenza vaccines in pediatric HCT recipients over consecutive seasons. However, the study's power was limited to detect differences in the initial season, and the findings may not be generalizable to patients with active GVHD or those receiving rituximab. Further research is needed to confirm these findings in broader populations.

 

Table 2 References:
[9] Bahakel H, Spieker AJ, Hayek H, et al. Immunogenicity and reactogenicity of high- or standard-dose influenza vaccine in a second consecutive influenza season. The Journal of Infectious Diseases. 2025;231(1):e123-e131. doi:10.1093/infdis/jiae454