Phase 4 randomized trial of intradermal low-antigen-content inactivated influenza vaccine vs. standard-dose intramuscular vaccine in HIV-1-infected adults

Ansaldi, Filippo; Valle, Laura; Florentiis, Daniela de; Parodi, Valentina; Murdaca, Giuseppe; Bruzzone, Bianca; Durando, Paolo; Setti, Maurizio; Icardi, Giancarlo

doi:10.4161/hv.20347

Cited by 12 publications

(13 citation statements)

References 21 publications

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“…However, few studies in PLWHA have examined antibody responses to vaccine delivered by an ID vs IM route, and none have compared standard-dose ID to standard-dose IM vaccine. Studies comparing low-dose ID to standard-dose IM vaccine have found noninferiority of low-dose ID vaccine [20–22]. Given previous findings, it was somewhat surprising that ID vaccine did not elicit higher HI responses 1 month postvaccination in our study.…”

Section: Discussionsupporting

confidence: 52%

“…ID delivery is thought to be more efficient than IM delivery because of the abundance of immunostimulatory cells in the dermis that act as potent antigen presenting cells [19]. Several studies have found no difference in antibody responses when comparing reduced-dose ID (3 µg hemagglutinin [HA] [20, 21] or 9 µg HA [22]) with standard-dose IM vaccines (15 µg HA) among PLWHA. Although some studies have demonstrated superior immunogenicity of equivalent-dose ID vs IM vaccine in older adults [19, 23, 24], no comparable studies have been conducted among PLWHA.…”

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confidence: 99%

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Randomized Controlled Trial to Compare Immunogenicity of Standard-Dose Intramuscular Versus Intradermal Trivalent Inactivated Influenza Vaccine in HIV-Infected Men Who Have Sex With Men in Bangkok, Thailand

et al. 2015

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Background Individuals infected with human immunodeficiency virus (HIV) are at increased risk for severe influenza, yet immune responses to standard-dose intramuscular (IM) influenza vaccine are suboptimal in this population. Intradermal (ID) delivery of influenza vaccine might improve immune response through enhanced stimulation of dendritic cells. Methods We conducted a randomized, double-blind, controlled trial to compare the immunogenicity of off-label standard-dose (15 µg) ID vs standard-dose (15 µg) IM inactive influenza vaccine in HIV-infected men in Bangkok, Thailand. The primary study outcome was seroconversion (minimum titer of 1:40 and ≥4-fold rise in antibody titer) at 1 month postvaccination based on serum hemagglutination inhibition antibody titers against each vaccine strain. Adverse events (AEs) in the 7 days following vaccination were also assessed. Results We enrolled 400 HIV-infected participants; 200 were randomly assigned to receive IM and 200 ID vaccine. Vaccine arms were well-balanced with respect to age, CD4 cell count, HIV RNA load, and antiretroviral treatment. Percentage of seroconversion to all (ID 14% vs IM 15%; P = .8) or at least 1 (ID 69% vs IM 68%; P = .7) of the 3 vaccine strains did not differ significantly between ID vs IM vaccine recipients. A higher proportion of participants who received ID vaccine had mild injection-site AEs compared with participants who received IM vaccine (77% vs 27%). Conclusions There were no significant differences in the immunogenicity of standard-dose ID vs IM influenza vaccine in this HIV-infected population in Thailand. Additional strategies to enhance immune responses to influenza vaccine among HIV-infected persons are needed.

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Section: Discussionsupporting

confidence: 52%

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confidence: 99%

Randomized Controlled Trial to Compare Immunogenicity of Standard-Dose Intramuscular Versus Intradermal Trivalent Inactivated Influenza Vaccine in HIV-Infected Men Who Have Sex With Men in Bangkok, Thailand

et al. 2015

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“…To our knowledge, only one study has evaluated the immunogenicity and safety of the intradermal vaccine in HIVinfected individuals. 17 The study compared a low-antigen-content intradermal vaccine (9 mg HA per strain) with a conventional intramuscular vaccine (9 mg HA per strain), and targeted HIV-infected adults. The reported seroprotection rate was approximately 80% and the seroconversion rate was nearly 50-60%.…”

Section: Discussionmentioning

confidence: 99%

Safety and immunogenicity of influenza vaccine among HIV-infected adults: Conventional vaccine vs. intradermal vaccine

Seo

Jacob

Song

et al. 2015

Human Vaccines & Immunotherapeutics

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Several studies have reported poor immune responses to conventional influenza vaccines in HIV-infected individuals. This study sought to elicit more potent immunogenicity in HIV-infected adults using an intradermal vaccine compared with a conventional intramuscular vaccine. This multicenter, randomized, controlled, open-label study was conducted at 3 university hospitals during the 2011/2012 pre-influenza season. Three vaccines were used in HIV-infected adults aged 18 - 60 years: an inactivated intramuscular vaccine (Agrippal), a reduced-content intradermal vaccine (IDflu9μg) and a standard-content intradermal vaccine (IDflu15μg). Serum hemagglutination-inhibiting (HI) antibodies and INF-γ ELISpot assay were measured at the time of vaccination and 1 month after vaccination. Adverse events were recorded for 7 d. A total of 28 Agrippal, 30 IDflu9μg, and 28 IDflu15μg volunteers were included in this analysis. One month after vaccination, the GMTs and differences in INF-γ ELISpot assay results were similar among the 3 groups. Seroprotection rates, seroconversion rates and mean fold increases (MFI) among the 3 groups were also similar, at approximately 80%, 50-60% and 2.5 - 10.0, respectively. All three vaccines satisfied the CHMP criteria for the A/H1N1 and A/H3N2 strains, but not those for the B strain. In univariate analysis, no demographic or clinical factors, including age, CD4+ T-cell counts, HIV viral load, ART status and vaccine type, were related to failure to achieve seroprotection. The three vaccines were all well-tolerated and all reported reactions were mild to moderate. However, there was a tendency toward a higher incidence of local and systemic reactions in the intradermal vaccine groups. The intradermal vaccine did not result in higher immunogenicity compared to the conventional intramuscular vaccine, even with increased antigen dose.

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“…[73][74][75][76] Immunogenicity has been explored also in immunocompromised patients: in transplanted patients, [77][78] in HIV-infected patients, 79 and in cancer patients. 80 Immunogenicity profiles of ID vaccines are not inferior to IM vaccines, as proven by some recently 89 Tsang and collaborators performed a randomized, controlled, multicenter, phase II study in older adults (≥65 years of age) who were randomly assigned to ID vaccine with 15μg (HA)/strain (n=636), ID vaccine with 21μg HA/strain (n=634), standard IM vaccine with 15μg HA/strain (n=319) and high-dose IM vaccine with 60μg HA/strain (n=320), respectively.…”

Section: Cutaneous Drug and Vaccine Deliverymentioning

confidence: 99%

Fluzone® intra-dermal (Intanza®/Istivac® Intra-dermal): An updated overview

Bragazzi

Orsi

Ansaldi

et al. 2016

Human Vaccines & Immunotherapeutics

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Influenza is a highly contagious respiratory acute viral disease which imposes a very heavy burden both in terms of epidemiology and costs, in the developed countries as well as in the developing ones. It represents a serious public health concern and vaccination constitutes an important tool to reduce or at least mitigate its burden. Despite the existence of a broad armamentarium against influenza and despite all the efforts and recommendations of international organisms to broaden immunization, influenza vaccination coverage is still far from being optimal. This, taken together with logistic and technical difficulties that can result into vaccine shortage, makes intra-dermal (ID) vaccines, such as Fluzone® ID and Intanza®, particularly attractive. ID vaccines are comparable and, in some cases, superior to intra-muscular/sub-cutaneous vaccines in terms of immunogenicity, safety, reactogenicity, tolerability and cross-protection profiles, as well as in terms of patient preference, acceptance and vaccine selection. Further advances, such as Fluzone® ID with alternative B strains and Quadrivalent Fluzone® ID or the possibility of self-administering the vaccines, make influenza ID vaccines even more valuable.

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Phase 4 randomized trial of intradermal low-antigen-content inactivated influenza vaccine vs. standard-dose intramuscular vaccine in HIV-1-infected adults

Cited by 12 publications

References 21 publications

Randomized Controlled Trial to Compare Immunogenicity of Standard-Dose Intramuscular Versus Intradermal Trivalent Inactivated Influenza Vaccine in HIV-Infected Men Who Have Sex With Men in Bangkok, Thailand

Randomized Controlled Trial to Compare Immunogenicity of Standard-Dose Intramuscular Versus Intradermal Trivalent Inactivated Influenza Vaccine in HIV-Infected Men Who Have Sex With Men in Bangkok, Thailand

Safety and immunogenicity of influenza vaccine among HIV-infected adults: Conventional vaccine vs. intradermal vaccine

Fluzone® intra-dermal (Intanza®/Istivac® Intra-dermal): An updated overview

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